FDA MAUDE database search

What MAUDE is

MAUDE is the Manufacturer and User Facility Device Experience database. It holds the medical device reports (MDRs) that FDA receives about suspected device-associated deaths, serious injuries and malfunctions. FDA describes it as a passive surveillance system. It records what people report. Nobody goes looking for events.

FDA's own MAUDE search page covers the last ten years of reports and updates monthly with reports received through the last day of the previous month. Older reports are in the MDR data files FDA publishes for download. FDA's MDR page says the agency receives over two million reports a year.

This tool reads openFDA's copy of MAUDE instead. openFDA says its copy runs from about 1992 to the present and is refreshed weekly. Each result links to the same report on FDA's MAUDE site, so you can check it at source.

How to search MAUDE with this tool

Fill in one field or several. Each field you add narrows the result. Results come back newest first, ten to a page, and the address bar always holds the exact search, so you can copy it into an email or a ticket.

• Device or brand name. Matches the brand name, the generic name and FDA's standardized device name as a phrase. Searching insulin pump finds reports under dozens of brand names.
• Manufacturer. Matches the manufacturer in section D of the report, the maker of the suspect device. Spelling varies between reports, so search the short name, such as Medtronic.
• Product code. FDA's three-character code for a type of device. It is the same code the 510(k) search uses, and the most reliable way to collect every report on one kind of device.
• Event type. Death, Injury, Malfunction or Other.
• Device or patient problem. Matches the coded problems on the report, such as battery failure or infection.
• Words in the narrative. Matches the free text of the event description and the manufacturer's narrative.
• Received by FDA. A date range on the day FDA received the report. This is not the day the event happened.
• Report number or MDR report key. Finds one report. Use it when someone cites a number.

These searches are a starting point:

• Deaths reported for external pacemakers (product code DTE)
• Insulin pump injuries received in 2025
• Medtronic reports that mention a lead fracture
• Battery problems on defibrillators

Who reports to MAUDE

Two groups file reports. Mandatory reporters are manufacturers, importers and device user facilities. Voluntary reporters are health care professionals, patients, caregivers and consumers, who report through FDA's MedWatch program on Form FDA 3500.

A device user facility is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility or outpatient treatment facility. A physician's office is not one. The report source on each result tells you which group filed it. openFDA's values are manufacturer report, distributor report, user facility report and voluntary report.

In openFDA's copy, the great majority of reports are manufacturer reports. That follows from the rules: manufacturers carry the widest reporting duty, including malfunctions, and user facilities are not required to report malfunctions at all.

Mandatory and voluntary reporting

The Medical Device Reporting regulation, 21 CFR Part 803, sets who must report what and by when. FDA summarizes the duties on its mandatory reporting page:

Everything else is voluntary. A user facility that sees a malfunction, or a clinician or patient who sees any product problem, can report it through MedWatch. A voluntary report does not have to meet the mandatory thresholds, which makes it a different kind of evidence from a manufacturer's 30-day report.

Report numbers show the source. Reports from mandatory reporters generally carry the submitter's registration number, the four-digit year and a sequence number, such as 3004593495-2020-00473. Voluntary report numbers begin with MW.

What a MAUDE report contains

FDA publishes a field-by-field description. These are the fields you will use most, with FDA's definitions:

A report can list more than one device. This tool shows the first device and notes how many more the report names.

Event types and report types

Event types

The rule defines the terms. A death is a death the reporter believes the device caused or may have contributed to. A serious injury is an injury or illness that is life-threatening, causes permanent impairment of a body function or permanent damage to a body structure, or needs medical or surgical intervention to prevent that. A malfunction is a failure of a device to meet its performance specifications or otherwise perform as intended. A small number of reports are typed Other, left blank or marked No answer provided.

FDA is explicit about the first of these. A report should not be classified as a death unless the reporter believes the device was or may have been a factor. A narrative that contains the word death is not by that fact a death report.

Report types

• Initial and follow-up. When a follow-up arrives, MAUDE shows the most recent information and adds to certain fields. You see the current state of a report, not its history.
• Summary reports. One report can describe many events. FDA's Voluntary Malfunction Summary Reporting program lets eligible manufacturers file summaries of malfunctions, and the Number of events summarized field says how many a report covers. Counting reports is not counting events.
• Exemptions. Reports filed under an exemption, variance or alternative granted under 21 CFR 803.19 carry an exemption number. Numbers shaped RWDYYXXXXX mean the manufacturer drew the information from real-world data sources such as registries, health records or claims.
• Forwarded notices. A manufacturer or importer that receives adverse event information about a device it did not manufacture or import must forward it to FDA under 21 CFR 803.22(b)(2). FDA adds a statement to the narrative saying so.

Two older streams are not in FDA's MAUDE search. Reports from the Alternative Summary Reporting Program, which ran from 1999 to April 2019, and reports from FDA's legacy Device Experience Network, 1984 to 1996, are posted on the MDR data files page instead.

What MAUDE cannot tell you

FDA states the limits plainly. MDR data is not intended to evaluate rates of adverse events, to evaluate a change in event rates over time, or to compare event rates across devices. Read every result with that in mind.

• A report is not a finding. Under 21 CFR 803.16, a report does not necessarily reflect a conclusion by the submitter or by FDA that the device caused or contributed to the event. The reporter may deny it.
• There is no denominator. MAUDE holds no count of how many devices are in use. A device used in millions of procedures will have more reports than one used in thousands, even if it is safer.
• Under-reporting is built in. FDA lists under-reporting, inaccuracies, lack of verification and lack of information about how often a device is used as reasons the incidence or cause of an event cannot be determined from MAUDE alone.
• The newest months are the least complete. A manufacturer has 30 days from becoming aware, and FDA posts monthly. Reports for a recent event keep arriving for weeks.
• Names are not standardized. One manufacturer can appear under several forms of its name, and a brand can be spelled several ways. Search the short form, then read the results.
• Some fields are messy. In openFDA's copy, the same reporter category appears as Foreign, FOREIGN and FOREIG, patient outcomes mix words with one-letter codes, and a few records carry dates that cannot be right, such as one received in 1900. This tool tidies outcomes for display and leaves everything else as FDA published it.
• Some text is withheld. FDA replaces trade secret text with (b)(4) and personal or medical file information with (b)(6). A narrative can read as if a sentence is missing because it is.
• Reports are not independent. One event can reach FDA from a hospital, a manufacturer and an importer, and each may file.

FDA treats MDRs as one of several postmarket data sources. Registries, clinical studies and recalls cover what MAUDE cannot. A company's own post-market surveillance program should draw on all of them.

How to read a narrative

The narrative is where a report becomes useful, and it is usually short and written in capital letters. Read it in this order:

1. Check the event type against the story. A report typed Malfunction with no patient harm is a different signal from one typed Injury.
2. Separate the voices. The event or problem description is the reporter's account. The additional manufacturer narrative is the manufacturer's investigation.
3. Look for evaluation. Did the manufacturer get the device back and test it, or does the conclusion rest on the reporter's account alone? The report records whether the device was available for evaluation.
4. Read the patient section. Patient problems and outcomes say what happened to the person. No consequences or impact to patient is a common entry.
5. Note redactions and boilerplate. Phrases such as a supplemental report will be issued if information is provided in the future are standard and carry no information.
6. Check the report type. A follow-up may have changed the account since the first filing.

Here is a short one. Report 3004593495-2020-00473, received by FDA on 27 April 2020, is a manufacturer report typed Malfunction on a temporary external pacemaker. The event description reads:

IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG), ATRIAL SENSE LIGHT EMITTING DIODE (LED ) WAS GREEN. THE EPG WAS RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

The reporter said the atrial sense light was green. The device went back to the manufacturer, which confirmed the fault, found a damaged seal and an incorrect part on the circuit board, replaced the parts and passed the unit on final testing. The patient problem is coded as no consequences or impact to patient. A reader learns what failed, that the manufacturer verified it, and that no harm was reported. A reader does not learn how many other units have the incorrect part. MAUDE cannot say.

How MAUDE relates to recalls and 510(k) clearances

MAUDE records events. A recall is an action on a product. A 510(k) is the clearance that let the product onto the market. They connect through a few fields, and each has its own tool:

• 510(k) clearances. The PMA or 510(k) number on a report names the marketing authorization for the suspect device. The product code groups it with similar devices. Search the code in the 510(k) search to see the clearance, the applicant and the other devices cleared under it. For a predicate review, the MAUDE history of the candidate predicate's product code is worth reading before you rely on it.
• Recalls. A report can name the remedial action taken, such as a recall. The link is thin: most reports never lead to a recall. To see what FDA has recalled for a failure mode, use the recall search.
• Device identity. A report may carry a UDI. If you have a device in hand, use the GUDID device lookup to find its brand, model and maker, then search those here.

For the actions that follow a quality failure, see CAPA, the Form 483 and the warning letter. An MDR is often the first public trace of the problem those documents later describe.

Other ways to get MAUDE data

• FDA's MAUDE search. The official interface. Covers the last ten years and shows every field FDA publishes.
• MDR data files. Zipped bulk files covering older reports. Voluntary reports run from June 1993, user facility reports from 1991, distributor reports from 1993 and manufacturer reports from August 1996. FDA updates them monthly.
• The openFDA API. What this tool uses. It is free. Without a key, openFDA allows 240 requests a minute and 1,000 a day per IP address. With a free key, the daily limit is 120,000.

To report a device problem yourself, use MedWatch. Clinicians, patients and caregivers can all file.

Frequently asked questions

What is the MAUDE database?

MAUDE is FDA's Manufacturer and User Facility Device Experience database. It holds medical device reports (MDRs) about suspected device-associated deaths, serious injuries and malfunctions, filed by manufacturers, importers, device user facilities and voluntary reporters such as clinicians and patients.

Is MAUDE data reliable enough to compare devices?

No. FDA says MDR data is not intended to evaluate event rates, changes in rates over time, or to compare rates across devices. The system relies on passive reporting, has no count of how many devices are in use, and a report does not prove the device caused the event.

Who has to report to MAUDE?

Manufacturers, importers and device user facilities must report certain events under 21 CFR Part 803. Manufacturers report deaths, serious injuries and certain malfunctions to FDA within 30 calendar days. User facilities report deaths to FDA and the manufacturer within 10 work days. Anyone else can report voluntarily through MedWatch.

What is the difference between mandatory and voluntary reports?

Mandatory reports come from manufacturers, importers and user facilities that are required to file. Voluntary reports come from health professionals, patients and consumers through MedWatch Form FDA 3500 and have report numbers that begin with MW.

How far back does MAUDE go?

FDA's MAUDE search shows the last ten years. FDA's downloadable MDR data files go back to 1991 for user facility reports and August 1996 for manufacturer reports. This tool reads openFDA's copy, which runs from about 1992.

How often is MAUDE updated?

FDA updates its MAUDE search monthly with reports received through the last day of the previous month. openFDA says it refreshes its copy weekly. This page prints the date of the newest report and the date openFDA last refreshed.

What do (b)(4) and (b)(6) mean in a MAUDE report?

They mark text FDA withheld under the Freedom of Information Act. (b)(4) replaces trade secret or confidential business information. (b)(6) replaces personal or medical file information, such as a patient's date of birth.

Does a MAUDE report mean a recall happened?

No. A report records an event. A recall is a separate action on a product. Some reports name a remedial action such as a recall, but most reports never lead to one.

Does this tool search FDA's MAUDE site?

No. It searches openFDA's copy of the same reports, live from your browser. Nothing you type is sent to Arca. Each result links to the same report on FDA's MAUDE site.

How do I report a problem with a medical device?

Use FDA's MedWatch program, online or on Form FDA 3500. Health professionals, patients and caregivers can all file. Manufacturers, importers and user facilities use Form FDA 3500A or its electronic equivalent.