The MAUDE database (Manufacturer and User Facility Device Experience) is the publicly accessible US database of the FDA for reports on incidents involving medical devices. In human factors and usability engineering, MAUDE serves as an important signal source for identifying known use-related problems, recurring reported event patterns and possible use-related risks.
The reports are called medical device reports (MDRs), not to be confused with the European Medical Device Regulation, which is also abbreviated MDR. The database contains mandatory reports from manufacturers, importers and healthcare facilities as well as voluntary reports from users, patients and healthcare professionals. In 2026, the FDA is transferring the reports previously provided via MAUDE to its new Adverse Event Monitoring System (AEMS); the name MAUDE remains in common use for the underlying data set.
Significance for human factors engineering
MAUDE is one of the most important publicly accessible sources of post-market data on medical devices in the United States. The database enables the analysis of reported deaths, serious injuries, product malfunctions and other presumably product-related events; a report alone is not yet a confirmed failure event. For human factors specialists, it provides indications of critical use scenarios, operating errors and unexpected interactions between users and products. Especially in early development phases, analyzing similar products can provide valuable insights for the use-related risk analysis.
Use in the usability engineering process
MAUDE data can be evaluated already during the analysis of use and context of use. Relevant events can be analyzed and used as input for the use-related risk analysis (URRA), that is, for identifying potential use errors, hazardous situations or use-related risks. The identified error patterns serve as input for design decisions on the user interface and for formative evaluations. They can also point to possibly critical tasks; the classification as a critical task must, however, be made on the basis of the product-specific sequences of events and possible harm and must not be derived from a MAUDE report alone. The database thus supports several steps of the development process conforming to IEC 62366.
Identifying use errors and use-related hazards
Not every report in MAUDE describes a technical defect. Many reports contain indications of operating errors, misinterpretations of displays, mix-ups of components or problems in device preparation. Such reports can be used to identify recurring use errors. The analysis requires a careful qualitative assessment, however, because the actual cause of an event is often not documented unambiguously.
Use for competitor and predicate analyses
In the regulatory environment, MAUDE is often used to investigate similar or competing products. Manufacturers can analyze known error patterns, recurring user problems or safety-relevant events for comparable products. The insights gained can flow into risk analyses, design inputs or the justification of usability measures. This approach is applied frequently, especially in the context of FDA approvals.
Limits and methodological weaknesses
MAUDE is not an epidemiological system. The number of reports does not allow statements about the actual frequency of a problem because the number of installed devices, the frequency of use and the extent of possible underreporting are unknown. In addition, reports can be incomplete, erroneous or duplicated. Causal relationships between device and event often cannot be established reliably from MAUDE data alone. The data should therefore always be assessed together with further information sources.
Systematic evaluation methods
For human factors investigations, MAUDE data are often evaluated by means of qualitative content analysis. Typical approaches include keyword searches, error classification, task mapping and assignment to known use-related hazards. For larger data volumes, statistical analyses, trend analyses or text mining are used in addition. The results should always be triangulated against further sources of evidence such as CAPA data, complaint files or literature searches.
Regulatory reference
Under the FDA medical device reporting (MDR) system (21 CFR Part 803), manufacturers, importers and certain healthcare facilities must report serious incidents and relevant product malfunctions to the FDA; these reports are published in MAUDE. The FDA describes MAUDE as a post-market surveillance data source for identifying potential safety problems of medical devices but explicitly points out that MAUDE data alone are not suitable for determining event rates, frequencies or for the direct comparison of products. For human factors and usability activities, post-market data can be used as input for identifying use-related risks; the explicit use of MAUDE is supported indirectly in relevant FDA human factors documents but not mandatory.
MAUDE provides valuable indications of real use problems but no frequency or risk indicators. The data unfold their value only through qualitative analysis and triangulation with further sources such as CAPA and complaint data.
Frequently asked questions (FAQ)
Can the number of MAUDE reports be used directly as a measure of risk?
No. The FDA explicitly points out that neither the actual event frequency nor the relative risk of a product can be derived from the number of reports. Reports are subject to reporting bias and incomplete capture.
Are MAUDE reports verified root cause analyses?
No. A MAUDE report documents a reported event, not necessarily the confirmed cause. Causality often has to be assessed through further investigation.
Is MAUDE suitable for identifying use errors?
Yes, but only after qualitative analysis of the individual cases. Many reports contain information on operating errors or user interactions that can be relevant for the use-related risk analysis.
Should MAUDE be considered when developing new medical devices?
In many cases yes. The analysis of similar products can make potential hazards, misuse and known weaknesses in use visible early and improve the completeness of the risk analysis.
Do you want to evaluate MAUDE and post-market data systematically for your use-related risk analysis? We support you throughout the usability engineering process according to IEC 62366-1.
More about our usability engineeringSources
- Regulation (EU) 2017/745 on medical devices (MDR)
- 21 CFR Part 803, Medical Device Reporting
- FDA MAUDE, Manufacturer and User Facility Device Experience Database
Related terms
- Known usability problems
- Known use error
- Post-market surveillance
- Use error