To Whom Have You Reported Your 'Adverse Event' ?
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).