How to Report a Medical Device Problem to the FDA (MedWatch)

Last reviewed Oct 16, 2026 · Based on FDA sources listed below · Editorial policy

Anyone can report a problem with a medical device to the FDA — patients and caregivers too, not only doctors. These reports help the FDA spot patterns that may lead to safety communications or recalls.

Who reports what

• Manufacturers, importers and device user facilities (such as hospitals and nursing homes) are required to report certain events: deaths, serious injuries and some malfunctions.
• Patients, caregivers and health professionals can report voluntarily through MedWatch, the FDA's safety reporting program.

How to report as a patient or caregiver

1. Open the FDA's MedWatch online reporting form and choose the consumer version (Form FDA 3500B). It can also be printed and mailed.
2. Describe what happened in your own words: what you were doing, what the device did, and what happened to you.
3. Add the device details: brand, model, lot or serial number, and the UDI if you have it. Where to find these numbers.
4. Keep the device and its packaging if you can — the manufacturer may ask to examine it.

You can also tell the manufacturer. Manufacturers must evaluate complaints and report qualifying events to the FDA.

What happens next

Reports go into the FDA's MAUDE database. Personal and medical information that could identify the patient or reporter is removed before publication. The FDA does not usually reply to individual reports, but it reviews them for trends. The public database is updated monthly, so a new report can take a month or more to appear.

Tips

• Report even if you are not sure the device caused the problem — evaluating that is the FDA's job.
• One clear, detailed report is more useful than several short ones.
• In an emergency, contact your healthcare provider or emergency services first.

This guide explains public FDA information. It is not medical advice — talk to your healthcare provider about decisions involving your device.

Sources

• FDA MedWatch online reporting ↗
• FDA: MedWatch Safety Information and Adverse Event Reporting Program ↗
• FDA: About the MAUDE database ↗

More guides

• How to Check if Your Medical Device Has Been Recalled
• Class I, II and III Medical Device Recalls: What They Mean
• What FDA Adverse Event Reports (MAUDE) Can and Can't Tell You