A useful medical device problem report tells the FDA exactly which device was involved (its name, manufacturer, and label numbers), what happened and when, and what the outcome was for the person using it. You can file a voluntary report online through MedWatch or by phone at 1-800-332-1088, and you do not need to be certain the device caused the problem. This guide turns the FDA's own reporting instructions into a checklist you can fill out before you report.
If someone is in danger right now, call your local emergency number first. A report to the FDA is not an emergency service and does not replace care. For a nonemergency problem, contact a health professional about any symptoms, then report.
What Reporting a Device Problem Means
The FDA's reporting program is called MedWatch, the FDA Safety Information and Adverse Event Reporting Program. The FDA defines an adverse event as “any undesirable experience associated with the use of a medical product in a patient.” Reports can also describe product problems, such as a device that malfunctions.
The FDA's Medical Device Reporting page says the agency encourages health professionals, patients, caregivers, and consumers to send voluntary reports of significant adverse events or product problems. Some reports are required. The same page explains that manufacturers must report when they learn a device may have caused or contributed to a death or serious injury, and it describes separate requirements for importers and “device user facilities” such as hospitals and nursing homes.
Where and How to Report
The FDA's consumer page on medical devices lists two options:
- Online: the MedWatch online reporting form.
- Phone: 1-800-332-1088.
The FDA's Reporting Serious Problems to FDA page also offers Form FDA 3500B, a consumer-friendly version of its reporting form, including a Spanish version. It also lists 1-888-INFO-FDA (1-888-463-6332); press 2 for MedWatch.
The FDA's form instructions say: “Do not send the product to FDA.”
Myths and Realities About Device Problem Reports
- Myth: You need proof the device caused the problem. Reality: The FDA's Form 3500 instructions say “it is not necessary to be certain of a cause/effect relationship” and “Suspicion of an association is sufficient reason to report.”
- Myth: Only doctors can report. Reality: The FDA encourages patients, caregivers, and consumers to report, and it offers a consumer-friendly form.
- Myth: If you don't know the exact date, you shouldn't report. Reality: The instructions ask for “the actual or best estimate” of when the problem started and say, “If day is unknown, month and year are acceptable.”
- Myth: “My device broke” is enough detail. Reality: The FDA asks reporters not to use “broad generic terms such as ‘catheter', ‘valve', ‘screw', etc.” The brand name, manufacturer, and label numbers identify the exact product.
- Myth: Filing a report makes your personal details public. Reality: The FDA says the patient's identity “is held in strict confidence by FDA and protected to the fullest extent of the law,” and it “will not disclose the reporter's identity in response to a request from the public.” For a serious adverse event, the FDA says it might share the reporter's contact details with the manufacturer unless the reporter checks a box on the form asking it not to.
- Myth: Reporting replaces calling your care team. Reality: A report helps the FDA monitor device safety. It does not get you medical care.
The Device Details Checklist
These items come from the device section of the FDA's Form 3500 instructions. Form 3500B, the consumer form, may word them differently. Gather what you can. Missing items should not stop you from reporting.
- Brand name: the trade name on the label or packaging.
- Common device name: a specific description of what the device is, not a broad term.
- Manufacturer: the full company name, city, and state.
- Model number
- Catalog number
- Serial number
- Lot number
- Expiration date
- Unique Device Identifier (UDI): if the label shows one. The FDA asks reporters to “record all numbers, letters, parentheses, and symbols included in the UDI #.”
- Implant and removal dates: only if the device was placed in, or removed from, the body.
Practical tip: photograph the label, box, and any insert before anything is thrown away, so you can copy each number exactly. For help reading what a label says, see our guide to medical device labels, intended use, and warning language.
The Event Details Checklist
The FDA's form asks for a written description of what happened, along with the relevant health details around the event. One way to organize it:
- Before: what the device was being used for and how the person was doing beforehand.
- The problem: what the device did or failed to do. Describe what you saw, heard, or measured.
- When: the date, or your best estimate.
- What followed: symptoms, any care received, and how things turned out.
- Tests: relevant test or lab results, including normal results.
- Relevant history: for example, existing health conditions and allergies.
If you track readings at home, notes made at the time can help you describe a suspected device problem accurately. Our guide to recording home monitoring device readings before a follow-up explains one way to keep those records.
Outcome Details: What the FDA Treats as Serious
The form asks about the outcome. The FDA's page What Is a Serious Adverse Event? lists these serious outcomes:
- Death
- Life-threatening
- Hospitalization (initial or prolonged)
- Disability or Permanent Damage
- Congenital Anomaly/Birth Defect
- Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- Other Serious (Important Medical Events)
The page adds that emergency room visits that do not lead to a hospital admission “should be evaluated for one of the other serious outcomes.”
Evidence Limits: What a Report Can and Cannot Show
- Review: the FDA's Medical Device Reporting page states, “The FDA reviews all medical device reports (MDRs) received.”
- Limits: the same page warns that “the incidence, prevalence, or cause of an event cannot be determined from this reporting system alone.” It cites under-reporting, inaccuracies, lack of verification that the device caused the event, and missing data on how often devices are used.
- Public data: the FDA's MAUDE database (Manufacturer and User Facility Device Experience) holds mandatory and voluntary reports. Because of the limits above, the number of reports for a device does not show how often problems actually happen.
- What we could not confirm: the FDA sources reviewed for this guide do not say whether the FDA replies to individual consumer reporters. Do not expect a personal response from filing a report.
To see whether the FDA has already addressed a device issue, check its Medical Device Safety Communications, which “describe the FDA's analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.” You can also check its medical device recalls list.
Conversation Worksheet
Copy these prompts into a note. Leave blanks where you don't know the answer.
Your Notes Before Reporting
- Device brand name and specific type: ________
- Manufacturer (name, city, state): ________
- Model / catalog / serial / lot / UDI / expiration: ________
- Date of the problem (or best estimate): ________
- What the device did or failed to do: ________
- Symptoms, care received, and outcome: ________
- Label and packaging photos saved? Yes / No
Questions for Your Health Professional
- Could what happened be related to the device, to how it was used, or to something else?
- Will you file a report, or should I?
- Is there anything in my health history that belongs in the report?
- What should I do about using this device for now? (Only your care team can answer this. Do not stop or change a prescribed device on your own.)
- Were any tests done that I should mention, including normal results?
What This Guide Is Not
This article explains how to organize information for a voluntary FDA report. It does not diagnose symptoms, judge whether any device is safe, recommend devices, or tell you to start, stop, or change any treatment. It is general information, not legal advice, and it does not explain the reporting duties of manufacturers or facilities beyond what the FDA sources above state.
Sources: FDA: Consumers (Medical Devices); FDA: Medical Device Safety Communications; FDA: Medical Device Reporting (MDR); FDA: Reporting Serious Problems to FDA; FDA: Instructions for Completing Form FDA 3500; FDA: What Is a Serious Adverse Event?
Medical information disclaimer: This content is for general education only and is not medical advice. Talk with a qualified health professional about symptoms or device concerns, and call local emergency services in an emergency. See our medical disclaimer, editorial policy, and non-affiliation notice. SIGMedical.net is an independent editorial publication. It is not affiliated with, endorsed by, or connected to SIG Medical Inc., Zimmer Biomet Holdings Inc., Penn State Health, Milton S. Hershey Medical Center, or any other entity previously associated with this domain, and it is not affiliated with or endorsed by the FDA.
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