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.