Manufacturer and User Facility Device Experience Database

The Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. MAUDE contains the last 10 years of medical device report (MDR) data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The public may search the database for information on medical devices that may have malfunctioned or caused a death or serious injury. Data for the past 10 years is available through the end of the previous month. The FDA seeks to include all reports received prior to each monthly update. Data more than 10 years old through 1995 is available in zip files by year.制造商与用户设施设备体验数据库（Manufacturer and User Facility Device Experience, MAUDE）收录涉及医疗设备的不良事件报告，该数据库包含近10年的医疗设备报告（Medical Device Report, MDR）数据。MAUDE可能未收录根据21 CFR 803.19规定获得豁免、差异许可或采用替代报告要求所提交的报告。可下载的数据文件涵盖1993年6月以来的自愿报告、1991年以来的用户设施报告、1993年以来的经销商报告以及1996年8月以来的制造商报告。社会公众可在该数据库中检索可能发生故障、导致死亡或严重伤害的医疗设备相关信息。近10年的数据可获取至上一个月末。美国食品药品监督管理局（Food and Drug Administration, FDA）致力于将每次月度更新前收到的全部报告纳入数据库。1995年及更早的、年限超过10年的历史数据可按年份以ZIP文件形式获取。