Report a medical device problem: consumers
Everyone who witnesses or experiences a problem with a medical device is strongly encouraged to report it. You can also work with your health care provider to submit a report. They may offer additional information that could be useful for our assessment.
Report a medical device problem
What medical devices 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.