Report a medical device problem: health care providers

Health care providers who witness, experience or hear about a medical device problem are strongly encouraged to report it. Talk to your patients about signs to watch for.

If you are a health care professional who works in a hospital, there are new mandatory reporting rules and a different form that you will need to use to report. Check with your administration to learn about any new requirements for your specific hospital.

Report a medical device problem

What products are included

Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits.

Devices are classified according to their level of risk, with Class I being the lowest risk and Class IV being the highest risk.

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