FDA MAUDE DATABASE 

What is MAUDE?

The U.S. Food and Drug Administration (FDA) hosts a publicly available database of the acronym MAUDE – Manufacturer and User Device Experience.  

As with any data and analysis formed from it, the adage remains, “arbage in, garbage out.” MAUDE data is only as good as the data that’s shared with the FDA. 

Medical device companies, and other mandatory reporters are required to share medical device reports (MDR) with the FDA. While we agree with the FDA’s warning that no person should draw summary conclusions from the data, we also believe this data can provide diabetics and their families with information that can be included to from decisions regarding diabetic care. 

The detail below is important to consider and found on the MAUDE website here:

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters   1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.

Please see the   MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA.

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.

The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.

MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.

Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester.

Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by “(b)(4)”. If a report contains personnel or medical files information, that text is replaced by “(b)(6)”. The designations “(b)(4)” and “(b)(6)” refer to the exemptions in the FOIA. For example, “(b)(4)” may be found in place of the product’s composition and “(b)(6)” may be found in place of a patient’s age.

MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.