MAUDE & MDR Databases Mismatch

Mark Meer

Trusted Information Resource
#1
I'm doing some searches on the FDA's MAUDE Database and MDR Search.

To keep it simple, I'm just searching by product-code (in this case, "NGX") over the last 10 years.

From the MAUDE, I get a bunch of hits, many of which state in the event text that "this issue was determined to be reportable as an MDR".

...but then I go to the MDR Search, and also to a search with the same parameters (ProCode: NGX, last 10 years), and get no results.

Can anyone speculate as to what is going on?
- Is the FDA slow to post MDR? (I'm dubious if this is the explanation as several of the MAUDE hits claiming MDR are over 5 years old).
- Perhaps the companies in question never reported, despite saying they would?

Any other possibilities? ...perhaps I'm misunderstanding the relationship between MAUDE and MDR?
 
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Mark Meer

Trusted Information Resource
#3
Hi Mark, I thought the MDR data base only went through to 1996 or 1997. Maude really only starts in 1997. There are entries before that, but I think there's a cross over period when they didn't match. Older Maude entries may be distributors, hospitals and the like.

https://www.fda.gov/downloads/training/cdrhlearn/ucm234355.pdf

Chris
Thanks Chris!
This makes more sense now. Essentially the MDR Search is obsolete it seems (unless searching for reports prior to July 31,1996).

I'm assuming that by "this issue is reportable as an MDR" lines in the MAUDE event texts simply means that it has and MDR report key? Not sure.

But in anycase, moving forward I think it's safe to disregard the MDR Search, as it appears to have been replaced by MAUDE for the last 20 years.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I think “reportable as an MDR” means that it’s reportable under 21 CFR 803 - Medical Device Reporting.
 

yodon

Staff member
Super Moderator
#5
Just to complicate matters (because that's what I like to do :) ) - there's also a MedSun database (Medsun Reports). I've not taken the time to figure out the difference between MedSun and MAUDE but they don't seem to overlap.
 
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