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Gold/Mining/Energy : PYNG Technologies

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From: mf160	9/9/2005 6:01:15 PM
	of 8117

Hey pictou thought maybe if you saw the paragraph in full since you never did really read it 2. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a) (1). For example, your firm failed to submit MDR reports to the FDA within 30 days for the following complaints: CC051,CC055, CC060, and CC064. These complaint numbers represent events that should have been reported as serious injuries. I posted 2 days after STANG put it up and mixed up what was written in the paragraph because I wrote it 2 days after I read the letter. Sort of like when you read the letter you ddin't even see the paragraph. I can tell you this legally it would be better to kill the patient than seriously injure (pain and suffering....) so maybe as a loyal pynger you might want to post you wish they would have died. as required by 21 CFR 803.50(a) since the FDA has both problems reported together I would tend to think they believe the 2 are equally troublesome.

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