From the FDA Re: Adverse Event Filings

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

From the FDA Re: Adverse Event Filings

PostPosted by DCNGA » Sat Jan 21, 2012 4:46 pm

From 2006: ... ersies.pdf

Report Side Effects After a Device is on the Market?

Q.What is the responsibility of device manufacturers after a device has been cleared by the FDA and is on the market? Is industry obligated to report side effects and complications? Also, what is the obligation of physicians to report complications that they encounter?

A.According to Mr. Richard Felten, Senior Reviewer and Photobiologist with the General Surgical Devices Branch of the FDA, Medwatch requires that industry report all adverse events that potentially could cause injury to patients.

Companies do not need to report a device failure if, for example, an inconsequential event took place such as a light bulb burned out. However, for example, if the fiber optics break and patients were burned, then that must be reported to us for evaluation. Industry must also keep records, which are reviewed during FDA inspections.

“It’s frustrating to us at the FDA that practitioners don’t always tell us about adverse events,”explained Mr. Felten. “I think that this happens because practitioners are so used to expecting things to happen that some events aren’t viewed as potential injuries. We estimate that at the FDA we see only about 10% of the actual adverse event reports due to us,” Mr. Felten added. “The other problem is that in many cases practitioners might be using a device off-label, so it could put a company in a bad quandary when asked for advice in solving the problem,” explained Mr. Felten. “By law, the company can’t tell you how to fix the problem because it doesn’t have approval for that use; therefore, they can’t talk about it because, by providing instructions for use, they can be viewed as no promoting the device for this off-label use.”
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