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)