MAUDE Adverse Event Database-File A Complaint If You Have Been Harmed By A Cosmetic Medical Device

For those who do not know, the FDA maintains a database for reporting adverse events from the use of any medical device, including cosmetic medical devices. This database is called MAUDE (Manufacturer and User Facility Device Experience). Although this is a terribly flawed system, it is a cosmetic device victim's only means of reporting these FDA approved devices to federal authorities. As it is now, the manufacturers fill out reports themselves and investigate themselves. Sadly, doctors/facilities rarely report adverse events as they should. I would imagine out of fear of a lawsuit or being ignored by the FDA. Nonetheless according to the Archives of Dermatology/VOL 142, FEB 2006" editorial (www.dcwderm.com/arch.pdf)

"it is estimated that only1%-2% of reportable events actually get reported..."

It is important to file an adverse event report if you have been harmed. Once you are on the first page of the form, you can skip this page if you do not wish to leave your information, although it is protected by the HIPPA law. You can file a complaint here:

Click "Begin" Button at This Link To File A Complaint

You may also file an adverse event report by:

telephone at 1-800-FDA-1088

fax at 1-800-FDA-0178

mail to:

MedWatch
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

From the MedWatch Website:

"MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.


However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.


You will receive an acknowledgement from FDA after your report is received. You will be personally contacted only if we need additional information.

What the FDA requires regarding Adverse Events from manufacturers:

"Adverse event reporting enables FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices.


Regulations require device manufacturers to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health issue. Regulations also require user facilities, such as hospitals and nursing homes, to report deaths to both the manufacturer, if known, and FDA within 10 working days. User facilities must report serious injuries to the manufacturers (or FDA if the manufacturer is unknown) within 10 working days. User facilities must also submit annual reports to FDA of all adverse event reports sent to manufacturers or FDA in the past year.

"Overall, FDA received twice as many adverse event reports for medical devices in 2007 than in 2003; however, some types of reports decreased. Manufacturers, user facilities, and other reporters submitted 72,866 medical device adverse event reports in 2003, which doubled to 150,210 reports in 2007. Manufacturers submitted the vast majority of these reports. Thirty-day reports of death, serious injury, and malfunction accounted for almost all manufacturer reports and drove the overall increase in adverse event reports."

Visit this link to see the adverse event reports filed from 2002-10/2010 regarding cosmetic devices detailing hundreds of adverse events surrounding these devices.