With the rise in use of medical devices, patients are often given very promising promotional videos and brochures from the manufacturers that show only the positive side of a device. The US FDA provides a very helpful live database that will allow you to directly view adverse events and/or complaints filed against a specific product.
MAUDE Database
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. An on-line search is available which allows you to search the CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
In the MAUDE database, you can search several variables including product name, manufacturer, date and type of adverse event, including death or severe. If you are considering having a medical device done, we strongly urge you to familiarize yourself with some of the adverse events reported so that you understand the complications that patients have and/or are currently experiencing. Infection is common as well as device malfunction.