FDA update adverse-event database

MASS DEVICE – Sept 21, 2020 – By Nancy Crotti 

In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices.

The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database (MAUDE).

The FDA also recently added a data field called “patient problem code,” an outcome code assigned to an adverse event. This has been available in drug reports but the device division redacted them from public view in the past, according to patient safety advocate Madris Tomes (CEO of Device Events and former FDA public health analyst).

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