Thursday, September 21, 2017

FDA Repairs its MAUDE Database

I have posted several times this year about an error in the FDA MAUDE database (see here, here and here for previous posts).

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?
  • etc.

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:

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