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Re: [IP] Pump Failure Data [Was] paradigm alarm ? MAUDE



On 12/3/02 2:30 PM, "Ember Crooks" <email @ redacted> wrote:

> Ok, so how does one file a report of this nature? Are they filed by the
> manufacturer or the consumer? I know I've seen more failures than that on
> this list alone.
> Ember

They need to be reported somewhere.  It was my understanding that the
manufacturers must comply and file reports of every complaint received.  I
know there are quite a few reports submitted which actually were due to user
errors.   Perhaps this site would be useful also.    :>)

     http://www.fda.gov/medwatch/report/consumer/consumer.htm

>> 
>> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
>> 

George
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