MAUDE is FDA's public database of medical device reports (MDRs) about deaths, serious injuries and malfunctions, and it holds the last ten years of reports [1]. Search it by product code to see which problems users report for a device type, but not to compare safety, because MDR data cannot measure event rates [1].
Key takeaways
- FDA received 2,888,003 device reports in 2025, and manufacturers filed 92.9% of them, based on our count of openFDA data [4].
- One product code, endosseous dental implants (DZE), made up 25.8% of all 2025 reports. That reflects how events are reported, not that implants are the riskiest device [4, 1].
- The MAUDE search form shows at most 500 results per search. Larger pulls need the monthly MDR Data Files or the openFDA API [2, 3].
- Manufacturers must report deaths, serious injuries and reportable malfunctions within 30 calendar days, and some events within 5 work days, under 21 CFR 803.50 and 803.53 [5].
- FDA received 2,924,614 reports from January to September 2026, more than in all of 2025 [4].
What is the FDA MAUDE database?
MAUDE (Manufacturer and User Facility Device Experience) is the public FDA database of medical device reports. Each MDR describes a suspected link between a device and a death, a serious injury or a malfunction [1].
Manufacturers, importers and user facilities such as hospitals must file these reports under 21 CFR Part 803 [5]. Patients, health professionals and other people can file voluntary reports on Form FDA 3500 (MedWatch) [5]. FDA publishes the reports in MAUDE, with trade secrets marked "(b)(4)" and personal data marked "(b)(6)" [1].
A report is not proof that the device caused the event. 21 CFR 803.16 states that a report is not necessarily an admission that the device caused or contributed to the event [5].
What does MAUDE contain, and how current is it?
MAUDE holds the last ten years of MDR data, and FDA updates it every month with reports received through the last day of the previous month [1]. Older reports, and some reports filed under 21 CFR 803.19 exemptions before June 2019, are only in the MDR Data Files [1, 3].
The MDR Data Files go back much further. They include voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993 and manufacturer reports since August 1996 [3].
Each report can include the product code, brand name, model number, 510(k) or PMA number, the UDI device identifier, problem codes, the event narrative and the patient outcome [1]. When a manufacturer sends a follow-up report, MAUDE shows the most recent information under the same report key [1].
How do you search MAUDE step by step?
Start with your product code, not a brand name. The product code groups every similar device, so you see the whole device type at once [2, 9].
- Find your product code in FDA's Product Classification database. For example, DZE is the code for root-form endosseous dental implants [9].
- Open the MAUDE advanced search and enter the product code [2].
- Set "Date Report Received by FDA" to a window you can read, such as the last 12 months. Each search shows a maximum of 500 results [2].
- Filter by Event Type: death, serious injury, malfunction, other or no answer provided [2].
- Narrow further with Brand Name, Model Number, PMA/510K Number, Product Problem or UDI-Device Identifier when you study one product [2].
- Read the narratives, not just the counts. The "Event or Problem Description" and the "Additional Manufacturer Narrative" explain what happened and what the manufacturer found [1].
- Record your search terms and date, so you can repeat the search later for trending or for your risk file.
For more than 500 reports, download the MDR Data Files or query the openFDA device adverse event API, which FDA updates regularly (last updated October 13, 2026) [3, 4]. FDA's TPLC database also combines MAUDE counts, recalls and premarket data by product code [8].
What did FDA's 2025 reports look like?
FDA received 2,888,003 device reports in 2025. Malfunctions were 59.9%, injuries 39.6% and deaths 0.46% [4].
| 2025 reports by event type | Reports | Share |
|---|---|---|
| Malfunction | 1,730,251 | 59.9% |
| Injury | 1,144,205 | 39.6% |
| Death | 13,286 | 0.46% |
| Other or no answer | 261 | under 0.1% |
| Total | 2,888,003 | 100% |
Manufacturers filed almost all reports. Under 21 CFR 803.30, user facilities send serious injury reports to the manufacturer, and to FDA only if the manufacturer is unknown. They send death reports to both FDA and the manufacturer [5].
| 2025 reports by reporter type | Reports | Share |
|---|---|---|
| Manufacturer | 2,684,279 | 92.9% |
| Importer or distributor | 180,811 | 6.3% |
| Voluntary (MedWatch) | 17,444 | 0.6% |
| User facility | 5,469 | 0.2% |
Four product codes produced more than half of all 2025 reports [4, 9].
| Product code | Device type | Class | 2025 reports |
|---|---|---|---|
| DZE | Root-form endosseous dental implant | II | 745,835 |
| QBJ | Integrated continuous glucose monitor | II | 379,891 |
| QFG | Alternate controller enabled insulin pump | II | 328,240 |
| OZP | Automated insulin dosing system | III | 152,969 |
Volume has risen since 2016, but not every year. FDA received 867,447 reports in 2016 and 2,888,003 in 2025, about 3.3 times more, while 2022 (2,945,385) was higher than 2025 [4]. By September 30, 2026, it had already received 2,924,614 reports for 2026 [4].
How we counted: We queried the openFDA device adverse event API on October 26, 2026 (data last updated October 13, 2026). We counted reports by "date received" for January 1 to December 31, 2025. Event type and reporter type come from the event_type and report_source_code fields. Product code counts use the device product code field, and one report can list more than one device. openFDA's own disclaimer says to treat its results as unvalidated [4].
Why can't you use MAUDE to compare device safety?
FDA states that MDR data is not meant to evaluate rates of adverse events, changes in rates over time or differences between devices [1]. MAUDE has no data on how many devices are in use, so a count is not a rate.
FDA names the main limits: under-reporting, inaccurate reports, no proof that the device caused the event, and no data on how often the device is used [1]. Counts also follow reporting habits. In 2025, 744,428 of the 745,835 dental implant reports were coded as injuries [4]. A high count for one product code can reflect how events are reported for that device type.
Summary reports add another limit. Since 2018, FDA's Voluntary Malfunction Summary Reporting (VMSR) program lets manufacturers of eligible product codes report some malfunctions in quarterly summary form [7]. One summary report can describe many events, so report counts and event counts are not the same [1, 7]. In 2025, MAUDE received 5,421 summary reports [4].
Use MAUDE for what it does well: finding failure modes, patient harms and use errors that real users report for your device type.
How should manufacturers use MAUDE in a 510(k) and a risk file?
Use MAUDE in three places: hazard identification, predicate research and postmarket trending. Each one needs a documented search that a reviewer can repeat.
- Risk management. Reported failure modes for your product code are inputs to your hazard analysis under ISO 14971. List each relevant failure mode and show the risk control for it.
- Predicate research. Search your likely predicates by 510(k) number. Repeated problems can shape your design, your testing and your labeling.
- Postmarket surveillance. After clearance, compare your own complaints with the reports for your product code. Written MDR procedures and MDR event files are required under 21 CFR 803.17 and 803.18 [5].
Doing this by hand takes time, because each search shows only 500 results and the narratives are long. Complizen's Risk Management module seeds a draft hazard list from the MAUDE history of your device type, which your team then reviews and edits.
For the full reporting rules, start with our MDR reporting hub and our guide to FDA adverse event reporting. For the other FDA databases, see our FDA medical device databases guide.
Who must report to FDA, and how fast?
Manufacturers report deaths, serious injuries and reportable malfunctions within 30 calendar days of becoming aware of them [5]. The deadline drops to 5 work days when an event needs remedial action to prevent an unreasonable risk of substantial harm, or when FDA asks for a 5-day report [5].
| Reporter | What to report | Deadline | Rule |
|---|---|---|---|
| Manufacturer | Deaths, serious injuries, reportable malfunctions | 30 calendar days | 21 CFR 803.50 |
| Manufacturer | Events that need remedial action, or FDA request | 5 work days | 21 CFR 803.53 |
| Manufacturer | Supplemental or follow-up information | 30 calendar days | 21 CFR 803.56 |
| Importer | Deaths and serious injuries (to FDA and manufacturer); malfunctions (to manufacturer) | 30 calendar days | 21 CFR 803.40 |
| User facility | Deaths (to FDA and manufacturer) | 10 work days | 21 CFR 803.30 |
| User facility | Serious injuries (to manufacturer, or FDA if unknown) | 10 work days | 21 CFR 803.30 |
| User facility | Annual report | By January 1 | 21 CFR 803.33 |
Manufacturers and importers must submit reports electronically (eMDR) under 21 CFR 803.12 [5]. FDA's MDR guidance for manufacturers, issued November 8, 2016, explains each requirement in detail [6]. Each report also needs FDA problem codes, which FDA lists on its MDR adverse event codes page [10].
What do manufacturers outside the US need to know?
Foreign manufacturers of devices sold in the US are manufacturers under Part 803, so they must file MDRs themselves [5, 6]. The exception is when FDA grants an exemption or alternative under 21 CFR 803.19 [5]. 21 CFR 803.58, which would have made the US Agent responsible for these reports, was stayed indefinitely in February 2014 [5].
Events outside the US can be reportable too. FDA's guidance says a foreign event is reportable if it involves a device cleared or approved in the US, or a similar device, that is also sold in that country [6]. So a complaint from Korea or Japan about a device also sold in the US can start a 30-day clock, if it meets the MDR criteria.
Plan for this before your first US sale. You need written MDR procedures (21 CFR 803.17), a working setup for electronic reports (21 CFR 803.12), and a complaint process that flags US-reportable events [5].
If you are preparing a first 510(k) and have no postmarket process yet, our free gap assessment shows what your file and procedures are missing.
Frequently asked questions
What is the MAUDE database?
MAUDE is FDA's public database of medical device reports about deaths, serious injuries and malfunctions. Manufacturers, importers, user facilities and voluntary reporters submit these reports. It holds the last ten years of data and FDA updates it every month. A report shows a suspected link only, not proof that the device caused the event.
Is the MAUDE database free to use?
Yes, MAUDE is free and needs no account. You can search it on FDA's website, download the monthly MDR Data Files, or query the openFDA API. The website search shows at most 500 results per search, so use the data files or openFDA when you need more than 500 reports.
How far back does MAUDE go?
The MAUDE search covers the last ten years of medical device reports. Older reports are in FDA's MDR Data Files, which include manufacturer reports since August 1996 and user facility reports since 1991. Some reports filed under 803.19 exemptions before June 2019 appear only in the data files, not in the MAUDE search.
How often is MAUDE updated?
FDA updates MAUDE every month. Each update adds reports received through the last day of the previous month. So a report FDA receives in October appears in the next monthly update. The openFDA API runs on its own schedule, and its last update date is shown in each response.
Can I use MAUDE to compare the safety of two devices?
No. FDA says MDR data should not be used to compare event rates between devices or over time. MAUDE does not show how many devices are in use, and reporting habits differ by device type. Use it to find failure modes and harms, then judge risk with other evidence such as recalls, studies and your own complaint data.
Why are there so many dental implant reports in MAUDE?
Root-form dental implants (product code DZE) had 745,835 reports in 2025, about a quarter of all reports, and 744,428 were coded as injuries. A high count can reflect how events are reported for this device type. It does not prove that dental implants are riskier than other devices.
Does a MAUDE report mean the device caused the injury?
No. Under 21 CFR 803.16, a report is not necessarily an admission that the device or the company caused or contributed to the event. FDA also says causation is hard to confirm from a single report. A report means someone had information that reasonably suggested a possible link and filed it.
How do I search MAUDE by product code?
Find your product code in FDA's Product Classification database first. Then open the MAUDE advanced search, enter the code and set the "Date Report Received by FDA" range. Add event type, brand name or 510(k) number to narrow the results. Each search shows at most 500 reports, so use short date windows.
How long does a manufacturer have to file an MDR?
Manufacturer reports of deaths, serious injuries and reportable malfunctions are due within 30 calendar days of becoming aware, under 21 CFR 803.50. A 5-day report is due when the event needs remedial action to prevent an unreasonable risk of substantial harm, or when FDA asks for one. Follow-up information is also due within 30 calendar days.
Do foreign manufacturers have to report adverse events to FDA?
Yes. A foreign manufacturer whose devices are sold in the US is a manufacturer under 21 CFR Part 803 and must file MDRs electronically. The US Agent reporting rule in 803.58 was stayed in 2014, so the duty stays with the manufacturer. Events in other countries can also be reportable to FDA.
What is the difference between MAUDE and the TPLC database?
MAUDE holds the individual medical device reports. FDA's Total Product Life Cycle (TPLC) database combines data by product code, including premarket submissions, recalls and MDR counts. Use TPLC for a quick overview of a device type. Use MAUDE when you need to read the individual reports and their narratives.
Can I get MAUDE data in bulk?
Yes. FDA publishes the MDR Data Files as zipped downloads, updated monthly. The openFDA device adverse event API also returns reports and counts by field, such as product code or event type. openFDA tells users to treat its results as unvalidated, so check important numbers against FDA's own files before you rely on them.
References
- FDA, About Manufacturer and User Facility Device Experience (MAUDE) Database, content current as of December 8, 2025. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database
- FDA, MAUDE search (advanced search form), page last updated September 30, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- FDA, MDR Data Files, accessed October 26, 2026. https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files
- openFDA, Device adverse event API, data last updated October 13, 2026, queried October 26, 2026. https://open.fda.gov/apis/device/event/
- 21 CFR Part 803, Medical Device Reporting, 2025 annual edition (govinfo). https://www.govinfo.gov/app/details/CFR-2025-title21-vol8/CFR-2025-title21-vol8-part803
- FDA, Medical Device Reporting for Manufacturers, final guidance, November 8, 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers
- FDA, Voluntary Malfunction Summary Reporting (VMSR) Program, accessed October 26, 2026. https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/voluntary-malfunction-summary-reporting-program
- FDA, Total Product Life Cycle (TPLC) database, accessed October 26, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
- FDA, Product Classification database, accessed October 26, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
- FDA, MDR Adverse Event Codes, accessed October 26, 2026. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes