MAUDE is the Manufacturer and User Facility Device Experience database from the FDA.
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
What are the plans for documenting how MAUDE is tidying its databases? I noticed that RAW data has been recently converted to ALL CAPS, separators changed, and the first row changed. What other changes are happening to RAW data set and where is this history being documented?
Here's an example from FOIDEV2010
"215"|"1939345"|"1969891"|"N"|"V"|"1"|"12/22/2010"|"UNK DEPUY ASR IMPLANTS"|"87KWA"|"DEPUY INTERNATIONAL, LTD."|"ST ANTHONYS RD||LEEDS||||UK|LS11 8DT||NA|UNK|UNK|NA|0HP|N||KWA|DA|R|||||||||||||||||
1939343|1970001|N|V|1|12/22/2010|UNK DEPUY ASR IMPLANTS|87KWA|DEPUY INTERNATIONAL, LTD.|ST ANTHONYS RD"|""|"LEEDS"|""|""|""|"UK"|"LS11 8DT"|""|NA|"UNK"|"UNK"|NA|"0HP"|"N"|""|"KWA"|"DA"|"R"|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""|""
Why is the new INDEX in col 1 added where it wasn't before? And why must I write this publicly when I would prefer submitting it in a more private email which is a more appropriate forum for observations like this!