Medical Devices

How to Report a Complaint or Problem

Report a Complaint

If you have questions or complaints about a baby product with medical claims, you can call FDA at 1-888-INFO-FDA (1-888-463-6332) or your local FDA district office. They will be able to tell you if the FDA has cleared or approved the medical device in question.

Report a Problem

If you experience an injury or malfunction when using a baby device, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Please include the following information in your reports:

  • Manufacturer’s Name
  • Device Name (Brand Name)
  • Date Device was Manufactured
  • Distributor’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if required)

For more information, see this Consumer Update on reporting a problem to the FDA: Reporting Problems to FDA (video)

Page Last Updated: 06/04/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.