![]() ![]() Death reports must be sent to the FDA and the manufacturer, if known. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Importers must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.ĭevice user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Manufacturers must send reports of such deaths, serious injuries and malfunctions to the FDA. Manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Exemptions granted and identified with "RWDxxxxxxx" in MAUDE, where RWD stands for real-world data, and xxxxxxx is replaced with a unique RWD exemption identifier, represent reports where the information submitted by the manufacturer was collected from certain real-world data sources, such as registries, electronic health records, or medical claims.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.Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years.Please see the MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. 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.Īlthough 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. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. ![]()
0 Comments
Leave a Reply. |