Defective Medical Device Reporting: The Basics

 Posted on August 22,2013 in Defective Medical Devices

When you're injured or ill and have a surgery to address the injury or illness, the last thing on your mind is dealing with a lawsuit after the fact. In fact, common sense dictates that after a traumatic event such as this, the most important step to recovery is to rest and avoid stressful endeavors—such as a lawsuit. Yet if you undergo a botched surgery, or have an implanted medical device that goes haywire, the most important thing you can do is address the issue right away. The longer you wait, even if it means disrupting recovery, the less chance you'll have at getting compensated for the financial, physical, and emotional hardship that can result from a bad surgery or defective medical device.

It's not only up to the patient to report a defective medical device, however. According to the Food and Drug Administration (FDA), which handles recalls of food, products, and goods that are deemed detrimental or dangerous, it is mandatory for a manufacturer to recall any device that the agency reports. According to the FDA, “the Medical Device Reporting (MDR) regulation contains mandatory requirements for manufacturers, importers, and user facilities to report significant medical device adverse events to the FDA.”

According to the FDA, “manufacturers are required to report to the FDA when they learn one of their devices may have caused or contributed to a death or serious injury.” As soon as the manufacturer becomes aware of this risk, the product must be recalled or the manufacturer can face heavy fines or penalties. Importers are also required to report knowledge of any defective medical device, as are user facilities (mostly hospitals and nursing homes). The FDA reports that, “user facilities should report a medical device-related serious injury only the manufacturer.” This means that the manufacturer is then responsible for reporting the defect to the FDA.

The FDA has a specific program for the voluntary reporting of defective medical devices by consumers and physicians known as MedWatch. The product can be reported through the MedWatch website.

If you or someone you know has been affected by a defective medical device, don't go through it alone. Contact an experienced defective medical device attorney today.