Chummie: Very Strong Deceit – Fraud on Amazon – Getting Amazon to Remove Negative Reviews.

We have reported earlier on Chummie’s Very Strong Deceit on Internet Review Sites, particularly Amazon. We have also raised the issue elsewhere in the blog wondering how Chummie had reduced (have deleted) many of the negative ratings they had received from legitimate Amazon customers. We particularly remember one long and detailed breakdown off all of the issues which this customer was having with the Chummie alarm. We recall seeing it, then it disappeared, then it was placed back in by the customer. In recent months it has not been on Amazon. We really do not understand why Amazon should have kowtowed to Chummie and removed a very honest, accurate, relevant, non-abusive review which said that the Chummie was a 1-star product, and explained why.

[for Chummie and its chums, whose knowledge of English is sparse:
kowtow - Definition [kou-tou, -tou, koh-]
(v.) To act in a servile manner
Source: Dictionary.com             ]

 Here is the review:

 Customer Review

3 of 6 people found the following review helpful Product does not work. Buyer Beware., October 11, 2012                 [This is a 1-star review, where the star is not reproducing on this blog site-Author] Product does not work. Buyer Beware., October 11, 2012 By  ballboy 99 Amazon Verified Purchase(What's this?) This review is from: Chummie Premium Bedwetting Alarm Blue. Over 100,000 alarms sold worldwide - Better Technology for Faster Treatment (Health and Beauty) NOTE: This is the second post of this alarm review. For some reason Amazon deleted my first one. Is this seller able to get negative reviews removed?? Isn't that a conflict of interest? I bought this alarm after reading the glowing customer reviews. I don't usually leave reviews, but had to make sure parents hear an honest account of why you should NOT purchase the Chummie. Wearing the alarm box on the neck is VERY uncomfortable and the sensor is a joke. Our son wet the bed about every night and often more than once a night. He was a very sound sleeper like most children with bedwetting. We bought the Chummie and it was a big mistake. First, the clip on the alarm unit. It is designed so that the alarm unit pokes your child in the neck if they wear it like it is designed. Look at the picture of the alarm unit on the child. If you wear a top with a regular neck opening think about where the alarm is going to sit - poking your child in the neck. Would you want to sleep all night with a hard plastic box poking you in the neck. As of this writing, they don't show you the back of the alarm unit. It is a small plastic piece that you have to hook on to your child's neck opening. The clearance is really small. You really can't lift it up and open it up enough so that it is really hard to hook up at night. If the cloth of the pajamas is thick, good luck in trying to getting it to work. This is an issue. It is really uncomfortable and my son hated it. Our son is average build and the clothing he wears has standard neck openings. Most people probably end up putting the alarm in the bed which really bothers me because of the strangulation hazard that this causes. Random Electrical Problems - We experienced numerous problems with the sounding of the alarm. Some times the alarm would just go off in the middle of the night for no reason. Other times the alarm would not stop sounding unless we removed the batteries. After so many problems we found that if we removed the batteries each night before bed, then reinserted them that the alarm would usually work that night. If you are experiencing the same problem, this is probably a solution. Sensor cord - pulls out of the alarm unit frequently. The sensor that you put on the underwear is connected to the alarm unit with an electronic plug. It just pushes in and doesn't lock in place. Sometimes our son would wake up wet and we would find that the sensor plug had come undone. Why doesn't this thing lock in place. Frequent false alarms. Poorly designed. Sensor - the sensor is a big disappointment. The marketing team made it sound good, but they needed a couple of parents with kids for testing. Sure, they made a sensor but no way to secure it to underwear. So what do they do? Give you a pack of Chummie bandages to tape the sensor to underwear. Let's get real. This is the 21st century. The adhesive is so poor and the bandages are so small they don't work. Do you really want to be using band aids every night trying to make the sensor stick to your kid's underwear? What if your child wets twice a night. It's 2 am and you are in your child's room trying to get the sensor to stick on with tape?  Harsh? No, just honest feedback. We have used an alarm in the past that was much superior to this "advanced" unit. I fell for the hype. Maybe you won't. When the Chummie includes cheap band aids to make their alarm work take it as a sign! Don't waste your money Help other customers find the most helpful reviews  Was this review helpful to you?  Report abuse | Permalink Comments Track comments by e-mail Sort: Oldest first | Newest first Showing 1-2 of 2 posts in this discussion Initial post: Oct 22, 2012 1:04:00 AM PDT Theos Medical Systems, Inc. says: The reason amazon removes these reviews is because we know it is the Bedwetting Store who is posting these reviews. We have been able to link these accounts and purchases to you. You are badmouthing the Chummie when you should be promoting your alarm which has reached its "end of life". Chummie is the ONLY alarm which works. We have revolutionized the bedwetting alarm with our modern patented technology which has helped over 100,000 children globally. Parents have a choice. Buy Chummie or buy an outdated alarm. In their best interest, they make the right decision and purchase the Chummie. Reply to this post Permalink | Report abuse 2 of 7 people think this post adds to the discussion. Do you?   In reply to an earlier post on Oct 22, 2012 1:21:35 PM PDT Truly Perceptive says: Theos says that "Chummie is the ONLY alarm which works." Capitalized ONLY. Everybody would be interested in knowing how you come to this amazing conclusion! Give us some good, valid, reliable substantiation! The next two sentences are also on the exceptional exaggeration list of Theos, as there is again no substantiation. And the last sentence, is undoubtedly part of a GIANT wish list that is the the only thing visible to Theos, so that they cannot even conceive anything else! Wow! Reply to this post Permalink | Report abuse 2 of 3 people think this post adds to the discussion. Do you?

Ballboy 99, you did a great service to people who are still being hammered by Chummie’s deceit. Your review and concern about Amazon’s attitude towards it are justified, as it has disappeared again. But it is resurrected here as a service to all people who want to know about Chummie and its deceitful methods. This is a great example!

Also note Chummie/Theos’s response. It certainly ranks very high on the list of most conceited, fake and goofy responses that we have seen. Truly Perceptive says what this entire blog has being saying about Chummie. Chummie and Theos are as fake as a $3 bill!

As has been historically true, Chummie probably will not respond to this review of yours. But we can always hope that Amazon will, if it is brought to their attention. We, and other readers of this blog, would certainly like to know about this review and why it disappeared from Amazon.


Note:

Chummie(TM) has a very large number of entries about its deceit in this blog. There are so many more entries and much more serious bad activities attributable to Chummie, so that Chummie has significantly more entries than all other manufacturers combined. You can read all of the Chummie deceit entries on this blog.

Chummie has also been given a 0-stars blog of its own so that its many examples of deceit can stand out by themselves. This Chummie blog is at
http://chummiedeceitcatcher.blogspot.com/ .


Chummie: Very Strong Deceit – Fraud on Amazon – Getting Amazon to Remove Negative Reviews.

Chummie: Desperation Deceit – No Defense – Only Loud Barking!

As we have been pointing out for over two months and covering well over twenty blog entries, Chummie has the very unique distinction of being by far the most deceitful party in the bedwetting alarm industry.

Many details of deceit by Chummie have been meticulously explained in this blog. If Chummie was an honest and non-deceitful party, they should have explicitly explained their position with respect to each and every allegation and piece of evidence, so as to attempt a legitimate defense.

It appears that Chummie has NO legitimate defense. No explanations to explain why the allegations are not true have been forthcoming. Chummie’s reaction has been typically Chummie: Send the attack dogs to bark as loudly as they can. This is also very consistent with deceit by perversion.

Chummie made extremely false accusations against DryBuddy and its parent company Enuresis Solutions, LLC, which were refuted in depth. One false accusation in which Chummie was mis-representing itself as the FDA and threatening Enuresis Solutions was even passed over to the FDA for their investigation and action. Chummie’s response to even this was to quietly delete these blog entries, but to no avail as copies were in the FDA’s (and our) possession.

We currently doubt that Chummie will ever attempt to refute the facts against it, as they are all true facts. Chummie would look and sound just as foolish attempting to refute them as they now do with all of their falseness exposed. Chummie’s barking defense is as empty as Chummie’s value system, containing little if any of honor, ethics, morals, or credibility! But they will keep on barking as this is the substance of their present character.

Even though the only legitimate and ethical approach would be to revoke and re-constitute themselves into an ethical entity, this would take unusual courage and ethical fortitude. We can always hope that Chummie will turn over to a new and good page.


Note:

Chummie(TM) has a very large number of entries about its deceit in this blog. There are so many more entries and much more serious bad activities attributable to Chummie, so that Chummie has significantly more entries than all other manufacturers combined. You can read all of the Chummie deceit entries on this blog.

Chummie has also been given a 0-stars blog of its own so that its many examples of deceit can stand out by themselves. This Chummie blog is at
http://chummiedeceitcatcher.blogspot.com/ .


Chummie: Desperation Deceit – No Defense – Only Loud Barking!

Chummie: Desperation Deceit

Chummie (and, of course, Theos Medical Systems) keeps extending its levels of deceit to ever higher levels. Not having the capacity or mental acuity to do anything original other than indulge in deceit, Chummie is now trying to imitate this site.

Chummie may never realize that imitation is the sincerest form of flattery. Unfortunately for them, they are so impaired that they are incapable of doing even a modest job of imitation, limiting their imitation to the use of the words "Bedwetting Alarm(s) Deceit." Beyond this, their postings are typically Chummie, with crude gesticulations, unoriginal ideas and the banalities that Chummie is known for.

As of the moment, we have noticed the following posts in Google search that can be attributed to Chummie:

·  Nytone Bedwetting Alarm Deceit Catcher - Pissed Consumer

www.pissedconsumer.com/...bedwetting-alarm/nytone-bedwetting-alarm...‎

Jul 31, 2013 - The Nytone Bedwetting Alarm is a Bedwetting Deceit by Perversion and Concealment. This is a truly horrible one of a kind Deceit in Totality.

 

·  Nytone Bedwetting Alarm: Deceit by Perversion and Concealment.

www.pissedconsumer.com/...bedwetting-alarm/nytone-bedwetting-alarm...‎

Jul 26, 2013 - I got ripped off by the Nytone Medical. The Nytone Bedwetting Alarm that they sent me was smelling of vomit. I spoke with someone in their ...

DryBuddy Bedwetting Alarm Lies and Deceit: DryBuddy Bedwetting ...

drybuddy-bedwetting-alarm-terrible.blogspot.com/.../waste-of-money.ht...‎

Jul 22, 2013 - Enuresis Solutions LLC has deployed full-scale lies, deception and deceit for promoting the DryBuddy Bedwetting Alarm. The lies are much ...

DryBuddy Bedwetting Alarm - Cheap Design, Poor Performance ...

drybuddybedwettingalarm.weebly.com/‎

DryBuddy Bedwetting Alarm uses deceitful tactics to sell wireless products that radiate dangerous levels of energy near your child's genitals. Create a free ...

Malem Bedwetting Alarm - Company Name Sucks

www.companynamesucks.com/malem-bedwetting-alarm---bedwetting-st...‎

Jul 26, 2013 - Malem Bedwetting Alarm - Bedwetting Store Sucks review posted on ... products sold by Bedewettingstore.com are Deceit by Concealment.

Nytone Bedwetting Alarm - ABC4.com - Salt Lake City, Utah News

www.abc4.com/...Bedwetting-Alarm/him5rHX6qUS5C0BBV7pRFQ.csp...‎

Jun 20, 2013 - Nytone Bedwetting Alarm. Sydney Weaver from Nytone shows a new ... Deceit by Perversion and Concealment. This product is high on deceit.

Ripoff Report | Nytone Medical Complaint Review Savannah ...

www.ripoffreport.com/.../Nytone-Medical-Nytone-Bedwetting-Alarm-is-...‎

1 day ago - Nytone Medical Complaint Review: Nytone Medical Nytone Bedwetting Alarm is a High on Deceit, Buyers Beware. Savannah Georgia.

We are not expert enough to say whether stupidity is a genetic trait, a learned (or unlearned) trait, or something else. But we must give Chummie a high grade for repeating obviously absurd inventions. These have generally been laid to rest, but Chummie and/or Chummies' flacks do not yet sense that with their very limited powers of creativity and thought.

So the story keeps unfolding, with Chummie providing new dimensions of craziness as they vent their spleen at Nytone, DryBuddy and Bedwettingstore. Why these? The answer can only be found in Chummie's weird mind.

This entire thing is becoming more and more entangling for Chummie. Does anyone want to help them move along faster? Perhaps they can tie themselves up so thoroughly in their own obfuscation, that they won't be able to save themselves from themselves. Remember the FDA fiasco?  See

http://www.bedwettingalarmsdeceitcatcher.blogspot.com/2013/08/v-behaviorurldefaultvmlo.html .

Cheers, everyone!


Note:

Chummie(TM) has a very large number of entries about its deceit in this blog. There are so many more entries and much more serious bad activities attributable to Chummie, so that Chummie has significantly more entries than all other manufacturers combined. You can read all of the Chummie deceit entries on this blog.

Chummie has also been given a 0-stars blog of its own so that its many examples of deceit can stand out by themselves. This Chummie blog is at
http://chummiedeceitcatcher.blogspot.com/ .

Chummie: Desperation Deceit

Deceit on the Internet: Shopping Reviews -- Reducing Fake Amazon Reviews.

Fake and deceitful reviews on shopping sites is a common occurrence. Amazon.com is the largest internet shopping site, and gets a tremendous number of reviews on a tremendous number of products and services that might be sold on Amazon. Undoubtedly, many of these reviews are fake and false. Some parties may almost be in the business of promoting their product and hurting competitors' products by fake reviews posted on Amazon by themselves or their flacks (shills). We have extensively reported on one such party in this blog.

We are aware that Amazon has procedures in place to try to prevent or reduce such bogus reviews. However, there is little doubt, that a substantial number of fake reviews get by Amazon's people who examine these reviews (we shall refer to them as Examiners). We feel that much of this is because of Amazons dedication to allowing a variety of expressions and opinions to be expressed. And Amazons criteria for allowing a review on its site is loose and often subject to interpretation by its Examiners. Unfortunately, the quality of Amazon's Examiners goes all over the place, from intelligent and willing to understand the circumstances for or against a review, to people who are incapable of going beyond a very literal reading of Amazon's rules, with no other considerations allowed. These latter Examiners have a favorite phrase which is often used - "This does not violate Amazon's rules."

This blog entry is not intended to be a critique of what may be wrong with Amazon's review policies. Our objective is to reduce deceit on the internet. So let us present an opinion expressed as a comment by Helen Smith on August 4, 2013 to our blog entry "Chummie: Grand Deceit -- Fizzle and Frazzle" which we posted on this blog on August 2, 2013. Helen's comments are reproduced below:

Helen Smith   August 4, 2013 at 9:10 AM

Hi,

I am repeating a comment I posted on an earlier entry on this blog, as it is applicable anywhere a seller is trying to prevent fake reviews. My suggestion relates to fake reviews on Amazon.

What you have said in an earlier blog Chummie: Grand Deceit -- Fizzle and Frazzle is so correct. I quote

"They have been very vociferous in their proclamations, many of them based on Chummie's deceit. They have screamed at anyone who called their bluff, or pointed out their flaws, or suggested any changes in their aggressive and deceitful practices and behavior. Chummie's response was often to invent even more deceit with which to threaten persons or parties that they felt threatened by. All with the intent to continue on their road of deceit.

They are obviously after DryBuddy, which must be scaring Chummie silly with their product(s). From what I have read in your entry "Chummie: Grand Deceit -- Part 2," Chummie will be facing a major competitive problem shortly.

With Chummie's established track record of deceit and manipulating reviews on sites like Amazon, I would bet that Chummie will be flooding Amazon with fake negative reviews on any product that DryBuddy places there. Other competitors might as well.

I am an Amazon seller in a completely different area. I have also had to endure fake negative reviews from competitors. I would suggest that DryBuddy considers doing what I do.

The review must come from a buyer who is both "Amazon Verified Purchase" and also "Real Name." Using just "Amazon Verified Purchase" lets people buy an inexpensive item and provide a fake review. And for a bad-mouthing competitor like Chummie, it may be worth spending $30 to be able to lie about your product. So by itself it is not reliable. But when you add "Real Name" to it, now will have only proper reviews from people who are willing to back up their review truthfully with their name.

For people who may have purchased the item directly from you, explain that they will have to use the "Real Name" on Amazon which matches their credit card "Real Name" when they ordered from you. Else it is probably a fake review.

Using both "Amazon Verified Purchase" and also "Real Name" has worked for me. Several genuine customers have informed me that my explaining this and branding an inappropriate review as a possible fake for these reasons has been very acceptable to them. And for people who want to lie, brand them and forget them. They may bring your Amazon rank down, but there isn't much you can do about fakes and liars, unless you also want to be like Chummie and massively flood Amazon with fake positive reviews.

I hope that this helps you and every other seller and buyer on Amazon and similar sites to try and keep reviews honest. I shall post it on some of your other blogs as well, and you may post this comment as a blog entry anywhere on your deceit related sites.

I appreciate the big effort that you have put into revealing deceit in the bedwetting alarm industry. We need this in other areas as well.

Good luck, and God Bless you.

Helen's idea merits consideration. State on your Amazon placement that if a buyer wishes to offer a review on Amazon, the purchase from Amazon must be made using the buyer's "Real Name" - the name on the credit card used for the purchase at Amazon. Although it is not impossible for such a name to be false, it is very likely to be a true name. Further state that a reviewer must have a "Real Name" as well as be an "Amazon Verified Purchase" for the review to be considered valid.

If the item can be purchased directly from the seller's site, the seller should state on the site that it must be purchased using the same name as on the credit card being used on the purchase. It must then be reviewed on Amazon with the same name which Amazon would certify as being a "Real Name." The seller could verify that this is a valid purchase from his/her site, since Amazon would not have labeled it as an "Amazon Verified Purchase."

Reviews that do not meet these criteria for proof of actual and valid purchase would be branded as "FAKE."

Explain this on your site and on your Amazon placement. People who do not wish to give or use their real name can still buy from either Amazon or the Seller's site using a pseudonym. But any review on Amazon would be label FAKE. As part of this FAKE label, state why the review has been so branded, since the buyer did not follow the conditions for a purchase which would be considered to be valid for a review on Amazon. These instructions would have been posted on both Amazon's and your site.

We recognize that Helen's idea may be difficult to follow for products sold by many sellers who do not have access to all sale records. But for numerous sellers selling unique items or limited to just selling on Amazon and/or their own site, it might work.

We do not know if this would be acceptable to Amazon. And although we understand Helen's viewpoint, there is some possibility that a potential customer may take umbrage for whatever reason. But, as stated earlier, if the customer does not intend to post a review on Amazon (and most don't) then using a pseudonym is not an issue at all.

As we said earlier, this merits consideration. Your feedback is welcome. Please make your feedback productive, participative and honorable, whether you agree with the idea or not. Suggest improvements to make it more feasible. It is important to all persons, buyers, sellers and Amazon, that reviews not be fake and prejudicial.

Please remember that our objective is to reduce and try to eliminate deceit on the internet. Reducing fake and bogus reviews on Amazon would be a substantial step in that direction, an objective that only the rogues can object to - and they would not do that publicly.

Thank you.

Chummie: Deceit by Perversion -- Best Buy

Chummie: Deceit by Perversion     http://www.chummie.com/buy-bedwetting-alarm-retail-store/           (August 5, 2013)

Chummie has never been shy about announcing anything that they wanted to announce. In this instance we are talking about their “Retail Partners” about whom Chummie has said a lot. They even have a special page on their web site (see above) where they display this list of “select retailers.”

Prominently listed on this page is Best Buy. We do know that Chummie was being sold at Best Buy. But for several months, if we clicked on Chummie’s “Buy Now” at their Best Buy link, on being sent to the Best Buy site, we would get the message:

We're sorry. We didn't find any matches for "chummie " in All Categories

So, to be certain about facts, we contacted Best Buy and asked about their carrying Chummie.

We were told that Best Buy terminated their relationship with Chummie and Theos Medical Systems some time ago. We did not get an exact date. But at least two months ago based on our experience with looking for Chummie on Best Buy’s site.

It appears that Best Buy decided that they no longer wanted to have any relationship with Chummie and Theos Medical Systems. Based on our ongoing analysis of Chummie, both the product and the company’s behavior, we can imagine why.

What is also obviously deceitful is that at least two months after they were dropped by Best Buy, Chummie continues to falsely brag on its web site that Best Buy is selling their device.

These deceitful facts just keep on continuing with respect to Chummie. Two or more months after their relationship with Best Buy was terminated, Chummie does not think it necessary to remove Best Buy from their list of “select retailers?”

And, of course, we have an appropriate copy of Chummie’s web page above, so we can always prove that Chummie was falsely and deceitfully advertising this item today (August 5, 2013). Let us see how long it takes Chummie to remove Best Buy from its web site. Of course, they could leave it there as a continuing reminder to people to buy Chummie from Best Buy!

And what might Chummie do if more of their “select retailers” get wise to Chummie and drop them?

Note:

Chummie(TM) has a very large number of entries about its deceit in this blog. There are so many more entries and much more serious bad activities attributable to Chummie, so that Chummie has significantly more entries than all other manufacturers combined. You can read all of the Chummie deceit entries on this blog.

Chummie has also been given a 0-stars blog of its own so that its many examples of deceit can stand out by themselves. This Chummie blog is at
http://chummiedeceitcatcher.blogspot.com/ .

Deceit by Perversion.

Chummie: Grand Deceit -- Fizzle and Frazzle

This is a factual presentation about deceit, deceivers, and (to use a somewhat theological phrase) how your sins can haunt you, all presented in a factual present-day set of circumstances.

The following is copied from Dictionary.com.

deceit

de·ceit [dih-seet]

noun

1.  the act or practice of deceiving; concealment or distortion of the truth for the purpose of misleading; duplicity; fraud; cheating: Once she exposed their deceit, no one ever trusted them again.

2.  an act or device intended to deceive; trick; stratagem.

3.  the quality of being deceitful; duplicity; falseness: a man full of deceit.

Synonyms:

1. deception, dissimulation. 1, 3. Deceit, guile, hypocrisy, duplicity, fraud, trickery refer either to practices designed to mislead or to the qualities that produce those practices. Deceit is the quality that prompts intentional concealment or perversion of truth for the purpose of misleading: honest and without deceit.  The quality of guile leads to craftiness in the use of deceit: using guile and trickery to attain one's ends. Hypocrisy is the pretense of possessing qualities of sincerity, goodness, devotion, etc.: It was sheer hypocrisy for him to go to church. Duplicity is the form of deceitfulness that leads one to give two impressions, either or both of which may be false: the duplicity of a spy working for two governments. Fraud refers usually to the practice of subtle deceit or duplicity by which one may derive benefit at another's expense: an advertiser convicted of fraud. Trickery is the quality that leads to the use of tricks and habitual deception: notorious for his trickery in business deals.

We have intentionally placed these extensive definitions of deceit here, so that the reader can understand and ponder about how so many ideas and concepts in the English language can be applicable to one single party and deceiver :

Chummie, and its parent Theos Medical Systems, Inc.

We already have about 20 blog entries relating to deceit by this one party, Chummie (please include Theos Medical Systems whenever Chummie is mentioned). They have extensively used every deception, trick, duplicity (please continue with the long list above) that they could conceive in their dealings with the public and others that they may have been exposed to. They have been very vociferous in their proclamations, many of them based on Chummie's deceit. They have screamed at anyone who called their bluff, or pointed out their flaws, or suggested any changes in their aggressive and deceitful practices and behavior. Chummie's response was often to invent even more deceit with which to threaten persons or parties that they felt threatened by. All with the intent to continue on their road of deceit (please use or substitute any or all of the words in the definitions and synonyms above).

And then they really blew it! They made such a big fake "invention" and mistake that they are now actually slinking away with their tail between their legs. Chummie could never admit to having made such a grand and ridiculous mistake. Admitting to an error (even one as grand as this) is well beyond the warped sense of ethics and morals that the culture of Chummie appears to be steeped in.

Analogy: When you have a very big mouth which is often spouting nonsense, it is quite easy to publicly put your foot in it! And once that event is photographed, you have to live with it forever.

So why is Chummie slinking? They got so carried away in their enthusiasm to bad-mouth and attack DryBuddy and its parent company, Enuresis Solutions, LLC that, amongst other concoctions, they invented a "Warning Letter" from the U.S. Food and Drug Administration's (FDA's) District Director, New Orleans District, warning DryBuddy of various misdeeds. This is addressed in the blog entry

Chummie: Grand Deceit -- Part 4.

And someone at Chummie, or associated with Chummie, eventually read this blog entry and actually understood or was "advised" that this was a major boo-boo with potentially major negative consequences for the free-wheeling Chummie!

So Chummie has quietly deleted this entire letter and its related episode from all of the attack blogs that they set up to bad-mouth DryBuddy. There were originally seven (7) blogs set up by Chummie, and they are listed in

Chummie: Grand Deceit -- Part 1.

As a consequence, not only have the blogs shrunk, but some are now empty and/or deleted.

However, there are those pesky photographs of Chummie posed with its foot in its mouth! The FDA has them. And so do we. We would not want to short-change Chummie's many fans by depriving them of the pleasure of witnessing one of Chummie's grand deceits.

So here is the first version that Chummie posted, in which they did not even place the name or full address of the party to whom the FDA supposedly sent this letter.

DryBuddy Bedwetting Alarm is Dangerous and Risky

Using the DryBuddy Bedwetting Alarm could put your child's precious life in danger. The DryBuddy system is not manufactured by DryBuddy, but a Chinese company with little care for your safety. With radiation levels higher than acceptable, DryBuddy wireless alarm may cause serious permanent damage to your child's vital genital organs. Learn more about the dangers and risk of the DryBuddy Bedwetting Alarm. Protect your child now.

 

Wednesday, July 24, 2013

Bedwetting Alarm Fails FDA Quality Inspection - Do Not Trust DryBuddy Alarm

We were able to get our hands on a letter the FDA sent to a Bedwetting Alarm manufacturer. We believe this letter was sent to Enuresis Solutions LLC, manufacturer of the DryBuddy Bedwetting Alarm

Would you still trust your child with this alarm?

July 18, 2017

WARNING LETTER NO. 2013-NOL-13

FEDERAL EXPRESS
OVERNIGHT DELIVERY

President and Owner
Savannah, GA 31406

Dear Sir/Madam,

During an inspection of your firm, located in Savannah, GA on July 10-11, 2013, an investigator from the United States Food and Drug Administration (FDA) determined your firm operates as the specifications developer and distributor of enuresis alarm devices. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820, (21 CFR820). Our investigator's observations were noted on the Form FDA 483, List of Inspectional Observations (FDA 483), issued  on July 10, 2013. A photocopy of the Form FDA 483 is enclosed for your review. These violations include, but are not limited to the following:

1. You failed to implement quality system procedures [21 CFR 820.20(e)] prior to the pre-announcement of the inspection on July 10, 2013. No devices should have been manufactured or distributed without a quality system in place.

2. You failed to implement Corrective and Preventive Action (CAPA) procedures before July 10, 2013, even though you have been a manufacturer. No devices should have been manufactured or distributed without CAPA procedures in place. For example, since June 2010 there have been [redacted] returned devices, and at least[redacted] of these related to a malfunction of your device.

3. You failed to maintain all acceptance records for devices as part of the device history records [21 CFR 820.80(e)]. For example, of the [redacted] lots of enuresis alarms received by you from the contract manufacturer since March 2009, only [redacted] had acceptance documents forwarded to you for review and approval

4. You failed to establish written procedures to define and document the review and disposition process for nonconforming product [21 CFR 820.90(b)(1)].

5. You failed to appoint a management representative to ensure quality system requirements are met, and to report to management the performance of the quality system [21 CFR 820.20(b)(3)].

6. You failed to establish, define, document, and implement adequate quality requirements [21 CFR 820.50(a)]. When you acquired the rights to the enuresis alarms, you changed the contract manufacturer without establishing acceptance criteria for the new manufacturer to meet quality objectives.

7. You failed to establish written procedures to cover the acceptance criteria for the finished enuresis devices [21 CFR 820.80(a)].

The inspection also revealed your devices are misbranded within the meaning of Section 502(t)(2) of the Act, 21 USC 352(t)(2), because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR 803 Medical Device Reporting (MDR) regulations. Specifically, you failed to develop, maintain, or implement MDR procedures [21 CFR 803.17], as noted on the FDA 483.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring your products into compliance.

Sincerely,

/S/

District Director
New Orleans District

This was an entire blog named http://drybuddy-bedwetting-alarm-risk.blogspot.com/ .

Chummie has since deleted the entry shown above.  You should also read Chummie's "presumptions" at the top which are also addressed in

Chummie: Grand Deceit -- Part 1.  and

Chummie: Grand Deceit -- Part 4.

We should add one more comment about this "FDA letter" that Chummie invented. It is apparent that Chummie's ability to truly invent useful and factual items or matters is extremely limited or non-existent. If they could read this letter and understand it, they might realize that the content of the letter relates to a Class III (3) device, and not a Class II (2) device which a bed wetting and enuresis alarm is. As a participant in the bed wetting and enuresis alarm industry, and having filled out an annual facility registration form and paid corresponding fees to the FDA, Chummie should know that what they sell is a Class II (2) device. To apply the stricter conditions of a Class III (3) in this letter is a further display of the disarray in Chummie's mental state and abilities. But this is what they saw somewhere and possibly could not understand much about it, except that it sounded scary. So they used it.

For further details and analysis of Chummie's attempts at Grand Deceit, please read the sequence of four blog entries on this blog titled

Chummie: Grand Deceit -- Part(s) 1, 2, 3 and 4.

Chummie totally lacks credibility!

We have so much more to say as a consequence of our ongoing analysis of Chummie and their methods. But we shall leave that for future blog entries.


Note:

Chummie(TM) has a very large number of entries about its deceit in this blog. There are so many more entries and much more serious bad activities attributable to Chummie, so that Chummie has significantly more entries than all other manufacturers combined. You can read all of the Chummie deceit entries on this blog.

Chummie has also been given a 0-stars blog of its own so that its many examples of deceit can stand out by themselves. This Chummie blog is at
http://chummiedeceitcatcher.blogspot.com/ .

Grand Deceit.