Manufacturers, user facilities and importers of medical devices are mandated to submit certain adverse events to the U.S. Food and Drug Administration [FDA]. Medical device reporting requires that manufacturers report to the FDA when they learn that one of their devices may have contributed to a death or serious injury. Consumers and health professionals can also voluntarily reports of adverse device events or product problems to the FDA through the MedWatch program.
Recently, the FDA has created a mobile application that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet. The app is designed for a more efficient to send information about these dangerous medical devices. The app allows the user to upload photographs of the defective device.
The FDA encourages consumers and healthcare professionals to report:
- Serious adverse events that might be associated with a medical device, especially events that are not listed in the product labeling. “Serious” means fatalities, hospitalizations, and medically significant events.
- Therapeutic failures where the device failed to work as it should.
- Use errors with devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.
- Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.
It is extremely important that these adverse events be reported so that manufacturers cannot hide behind the absence of information contending it is the equivalent of the absence of evidence of defect.
Contact Our Experienced San Francisco Drug Recall Lawyers Today
At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh. Instead of treating all victims of defective drugs and medical devices the same by throwing everyone into one class action lawsuit, we take a different, more personalized approach. We use our team of experienced defective drug attorneys to a build solid case for each client harmed by a specific defective drug or medical device.
Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions. Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.