![]() The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed. MAUDE is updated monthly and the search page reflects the date of the most recent update.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. The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. If a report contains personnel or medical files information, that text is replaced by "(b)(6)". If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA).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.Searches only retrieve records that contain the search term(s) provided by the requester. Variations in trade, product, and company names affect search results.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.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. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.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. 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. ![]() ![]()
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