Re: What is wrong with people? REALLY! OMG

By the way, you didn't keep reading about this and only posted the first
thing you found that MIGHT dispute me about the Vail beds....here's what you
didn't post:

snippet from Phyllis' post:

FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed
Systems until they receive additional instructions from Vail Products.

UNTIL THEY RECEIVE ADDIITONAL INSTRUCTIONS...don't throw them away, just
wait for the new instructions!!!!

Now here is the followup from vailbed.com...lol why do I get the feeling you
would have been led here first when Googling for Vail beds and decided to
not put this in your post?
?On June 24, without consulting with Vail Products as to accuracy or
appropriateness, the FDA issued a press release concerning new instruction
manuals that Vail Products distributed to its customers last week. In that
press release, the FDA stated that Vail Products had undertaken a ?recall.?
?Recall? is a term of art within the FDA that includes all changes to
medical devices, including new instructions or labels. It is not a recall of
the products, and there is no reason to discontinue use of the Vail Enclosed
Bed Systems. In our May 6, 2005 letter to customers reemphasizing certain
warnings and alerting customers to the new instructions that would be coming
out, we informed customers that as long as they follow the instructions
there is no reason to discontinue using the beds. The FDA approved that May
6 letter. The FDA?s unfortunate use of the word ?recall? in its June 24
press release is causing unnecessary confusion. Vail Products is not
recalling the beds in the sense of physically removing them, and there is no
reason to do so. As we said in the FDA-approved letter on May 6, the beds
are safe and effective for continued use as long as the instructions are
carefully followed.?

Dani
--
www.menkessyndrome.com
"Phyllis Nilsson" <phyllisnilsson@xxxxxxxxxxxxxxxxxxx> wrote in message
news:432C5B41.7020306@xxxxxxxxxxxxxxxxxxxxxx
> Sorry to piggyback, but this may explain why your solution is not a
> solution:
>
> FDA Asks U.S. Marshals to Seize Adulterated and Misbranded Hospital Bed
> Systems
>
> In a response to ongoing concerns about manufacturing quality and
> labeling, the Food and Drug Administration (FDA) and the Department of
> Justice today initiated seizures of all finished Vail 500, 1000, and 2000
> Enclosed Bed Systems made by Vail Products, Inc., located in Toledo, OH.
> Use of these systems poses a public health risk because patients can
> become entrapped and suffocate, resulting in severe neurological damage or
> death.
>
> FDA advises consumers to stop using Vail 500, 1000 and 2000 Enclosed Bed
> Systems until they receive additional instructions from Vail Products.
>
> FDA is aware of approximately 30 entrapments resulting from use of the
> Vail Enclosed Bed Systems, of which at least 7 resulted in death.
>
> The U.S. Marshal?s Office also seized welded in-process components and all
> labeling and promotional materials for the Vail 500, 1000, and 2000
> products.
>
> FDA believes the Vail products seized today do not meet with the Quality
> System regulations of the Federal Food, Drug and Cosmetic Act and pose
> significant health risk for consumers.
>
> The Enclosed Bed Systems are misbranded because they are dangerous to
> health when used in the manner, or with the frequency or duration
> prescribed, recommended, or suggested in the labeling. They are further
> misbranded because they lack adequate directions for use and adequate
> warnings, thereby placing patients at an increased risk of entrapment and
> asphyxiation.
>
>
> Phyllis Nilsson wrote:
>> Dani, it isn't the solution that we would pick if we had a choice, but
>> Vail beds have been recalled because people died in them and, from what I
>> understand, they are now out of business because of lawsuits. Since Vail
>> beds are no longer being made and you wouldn't choose a dog crate for a
>> child (neither did they, I read they were hand made) what other humane
>> way could you put together to keep these children safe? Putting our
>> emotions aside and looking at it from the standpoint of practicality,
>> what could you personally devise to keep these children safe?
>>
>> DJGordon wrote:
>>
>>> Well, I could have provided another humane way. Vail beds for all of
>>> them. Insurance covers them for special needs kids, so no excuse to be
>>> in a cage. Phyllis, do you really think that was an answer to a possible
>>> dilemma they had? Come on, do you go in your local pet store and see an
>>> ad on their cages that say, great for special needs kids too, they can't
>>> stretch out even. 40 inches, Phyllis, 40 inches and the oldest kid was
>>> 14. My daughter is 15 and is 66 inches. That's a solution?
>>>
>>> Dani
>>>
>>> Dani
>>>
>>
>


.

Relevant Pages

  • Re: What is wrong with people? REALLY! OMG
    ... FDA Asks U.S. Marshals to Seize Adulterated and Misbranded Hospital Bed Systems ... In a response to ongoing concerns about manufacturing quality and labeling, the Food and Drug Administration and the Department of Justice today initiated seizures of all finished Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., located in Toledo, OH. ... Systems until they receive additional instructions from Vail Products. ...
    (sci.med.transcription)
  • Re: What is wrong with people? REALLY! OMG
    ... > Systems until they receive additional instructions from Vail Products. ... > you would have been led here first when Googling for Vail beds and decided ... the FDA issued a press release concerning new instruction ... >> Enclosed Bed Systems made by Vail Products, Inc., located in Toledo, OH. ...
    (sci.med.transcription)