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Wednesday, August 30, 2017

Update # 2 on "8." MAUDE Database

I've previously written (here and here) about an error in the FDA medical device adverse events database known as MAUDE. The error prevents the database from reporting patient outcomes (death, hospitalization, etc.).

I received correspondence from someone at the FDA last week indicating that they may have found a fix (see screenshot of email).

However, so far, they have not implemented the fix. You can see this in two ways:

First, if you download the patient outcome file from the FDA website and open it up, you see a series of "8"s where the outcome data should be (see pic).

Second, you can query the MAUDE database using the OpenFDA platform and count the distribution of patient outcomes in the year:
As of this moment, if you click on this link, you will see the distribution of patient outcomes in the MAUDE database from the beginning of 2016 until yesterday. You can see from the pic below that there are no outcomes, only variations on "8."