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What is the reporting procedure for defective medical devices?

The research and development teams involved in the creation of medical devices put a great amount of work into each project. In turn, it is safe to assume that the manufacturers of these products attempt to ensure they are safe for patient use. Unfortunately, defective medical devices can pass the development and testing phase and still cause injury to residents of Tennessee.

When a defective medical device does lead to injuries, the reporting process is critical in getting the device off the market and eliminating any further injury risk. This benefits consumers and manufacturers because it protects parties on both sides of the issue.

There are two types of reporting: mandatory and voluntary.

Under federal requirements, mandatory reporters must submit reports involving adverse events associated with devices to the Food and Drug Administration (FDA). They must also make a report if they believe that a death or injury occurred because of a defective device. Examples of mandatory reporters include device manufacturers, importers and medical facilities where devices are used.

As the term indicates, voluntary reporting is not required, but it is a great way for the FDA and for manufacturers to learn about potentially defective medical devices. Anyone can make a voluntary report including doctors, patients, nurses, family members and care providers. The FDA makes it easy to report a possible defect and even offers an online portal people can use for reporting.

It is important to understand that even though a product has been recalled, injured parties can still take legal action against the manufacturer and possibly other parties for any negligent harm the device caused.

Source: U.S. Food and Drug Administration, "Medical Device Reporting (MDR)," accessed April 26, 2018

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