To summarize, the FDA's MAUDE database captures reports of malfunctions and injuries associated with medical devices. The MAUDE database is supposed to capture patient outcome information like:
- Did the patient die during/as a result of the device malfunction?
- Was the patient hospitalized due to the malfunction?
- Was the patient disabled?
About 2 years ago, the FDA's MAUDE database stopped reporting patient outcomes and replaced these outcomes with a cryptic code of "8.".
As you might imagine, this is a pretty serious omission. It seems kind of important to know what happened to the patients when a device malfunctions.
I contacted the FDA earlier this year and informed them of the error.
Today, I received an email indicating that the database has been fixed and the outcomes are back!
FDA was also kind enough to explain what "8." meant: