Yes. As you say it has been around a while. Basically, the idea was that FDA would get better reporting if they trained sites on how and what to report. So they picked a bunch of sites (I can't remember how now) and did training with them on MDRs, definitions of what is reportable etc. I think they were hoping it would turn into something like Sentinal on the drug side, but it never really did - I suspect because of the disconnects between doctors, nurses, risk managers etc. It isn't really a "separate" database to my knowlege, as these reports get integrated into MAUDE/MDRs eventually.
A couple of jobs ago, it wasn't uncommon to get an MDR forwarded to us from FDA that actually said MEDSUN on it.
g-
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Ginger Glaser RAC
Vice-President, Engineering
formerly VP, RA/QA
Monteris Medical
Minnesota, United States
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Original Message:
Sent: 09-Aug-2017 00:56
From: Julie Omohundro
Subject: MEDSUN?
Today I was astonished to learn that there is a whole separate database of medical device reports submitted by providers, established in 2002 and I never heard of it. It seems to have been an effort to make it easier for providers to report, and also to permit them to report anonymously.
Has anyone any knowledge of this database?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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