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How to Report a Medical Device Injury to the FDA

By Burg Simpson

November 27, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Products Liability

Medical devices can improve the quality of life for many people. However, defective medical devices can cause significant harm resulting in lifelong injuries. If you or a loved one has been harmed by a defective medical device, it is important that you speak to a product liability attorney as soon as possible. You may also want to report your injury to the FDA.

Medical devices are regulated and monitored by the United States Food and Drug Administration (FDA). Reports of injuries submitted to the FDA are important and can help the FDA detect potential safety problems. If you want to submit a report to the FDA, follow the steps listed below.

REPORTING A MEDICAL DEVICE-RELATED INJURY TO THE FDA

Fill Out a MedWatch Form (online form or printable form):

  1. Fill in your personal information
  2. Describe what happened
  3. Identify medical device and manufacturer
  4. Provide your contact information
  5. Indicate whether or not you wish to be contacted by the manufacturer

Submit a MedWatch Form:

  1. If using an online form, review and submit your report online.
  2. If using a printed form, review and follow directions for submission:
  • To send via Fax:

1-800-FDA-0179

  • To send via Mail (no postage necessary):

MedWatch

The FDA Safety Information and Adverse Event Reporting Program

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20852-9787

After suffering an injury, you may wonder if you are the only one to have this happen. Reports of medical device-related injuries are maintained in a publicly accessible database known as the MAUDE database. Through this database, you can search for injuries or experiences similar to yours. To learn more about searching the MAUDE database, see our previous post, “How to search FDA’s Adverse Event Databases.”

If you suspect that you or your loved one has been harmed by a medical device contact one of our experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning, compassionate attorneys would be happy to discuss your potential claim. Call (513) 852-5600 or fill out our contact form for a FREE no-obligation consultation today.­­­

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