To Whom Have You Reported Your 'Adverse Event' ?

Jane Akre
November 14, 2011

I have a question -

Assuming you've had a problem with synthetic surgical mesh, who have you reported your complications to? The manufacturer, the FDA?

Did you enter a report into the MAUDE database of the FDA, the only way the agency is able to track "Adverse Events" ? MAUDE is the only tool the FDA has to measure the complications and is thought to represent just a fraction of the actual injuries.

See earlier story on how to report to the FDA's MAUDE database (here).

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