How Do You Report a Medical Device Problem?
Find out how to report a medical device problem to the FDA, which issues MedWatch accepts, and what details make a device report more useful.
To report a medical device problem to FDA, use MedWatch and describe the device, what went wrong, and whether the problem involved an injury, malfunction, use error, or product-quality issue. Include the device brand, model, serial number, lot number, dates, and patient outcome when you have them.
Details that make a device report stronger
Device name
Identifies the product
Brand and common device type
Model or serial number
Narrows the affected item
Model, lot, UDI, serial
What happened
Explains the event
Stopped working, wrong reading, broke
Harm or risk
Shows seriousness
Injury, delayed care, near miss
Dates and setting
Adds context
Home use, hospital use, first use
Consumers can report device problems
MedWatch is not limited to hospitals. FDA's voluntary reporting path is available to consumers and patients when they observe or suspect a serious medical product problem.
File the device report
- 1Get medical help first if the device problem created immediate danger.
- 2Keep the device, packaging, label, and instructions if it is safe to do so.
- 3Collect model, serial, lot, date, and event details.
- 4Open the MedWatch voluntary reporting form for consumers or patients.
- 5Submit the report or save the report ID and report date if you need to finish within the allowed window.
FAQ
Can consumers report medical device malfunctions to FDA?
Yes. FDA's MedWatch form is available to consumers and patients, not only clinicians, for suspected adverse events, product quality problems, use errors, and device issues.
Do I need the device serial number to file a report?
Use the device serial, lot, model, or brand details if you have them, but do not delay urgent care or abandon a useful report just because one detail is missing.
Can I save a MedWatch report and finish later?
FDA says MedWatch Online can let reporters continue an incomplete report for a limited window when they have the report ID and report date.
Sources & method
We reviewed these references while writing this answer. Figures are estimates — confirm safety-critical work with a professional. Last updated June 7, 2026.
- MedWatch Online Voluntary Reporting FormFDA · accessdata.fda.govSupports the consumer and patient MedWatch form, the emergency warning, report-saving window, and the types of problems FDA asks reporters to describe.
- MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramFDA · fda.govSupports that medical devices are a MedWatch product category and that patients and consumers can report serious product problems.