The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements. Whether the product didn’t work as promised on the label, caused sickness or injury or malfunctioned or had defective components, the FDA wants to hear from you.
Post approval monitoring is the only way that the FDA can determine a pattern of failure of any particular product it oversees. The agency is working on a unique identifier (like a bar code) to better track devices, but until that regulation is put into place, reporting is voluntary by healthcare professionals and consumers. Without accurate reporting, there is no way to know how a device or drug is functioning under real world situations.
This new form was developed with the help of AARP, Consumers Union and the National Women’s Health Network. Here is the form.
Here is a lesson how to submit a report to MedWatch.
Consumers are encouraged to report adverse outcomes that are not listed on the product label; report therapeutic failures where it failed to work as it should; report user errors due to poor communication or ambiguities on the label; report problems with a product quality, a malfunction, poor packaging or defective components.
Even if you are not sure the problem is due to the product, you are encouraged to report to MedWatch (1-800-FDA-1088).
Meanwhile what is happening to MAUDE? In May, the FDA updated information on the MAUDE database (here). MAUDE stands for Manufacturer and User Facility Device Experience (MAUDE).
Manufacturers and health care providers and facilities are required to report adverse events (complications) to the MAUDE database, though the penalty for not doing so is less than clear.
Generally what happens is a doctor or an attorney will report to the MAUDE database. The manufacturer will generally add a Conclusion such as:
“Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.”
Generally that is the end of it. Critics of the FDA have called it a “black hole” when it comes to any adverse event reporting.
Regardless, here are instructions on how to post an adverse event report to the MAUDE database with the FDA.
Consumers Union on How to Improve the Safety of Medical Devices
MDND, Sept 2012, How to Follow Medical Devices: UDI Proposal