美国 FDA MAUDE 数据库中口腔科器械与设备类产品不良事件报告汇总分析

摘要

通过对美国 FDA MAUDE 数据库中口腔科器械与设备类产品不良事件报告进行统计分析，总结其不良事件特点，初步探讨其安全性影响因素，为公众用械安全提供保障。%By analyzing the adverse event reports of dental instruments and equipments which col ected from FDA MAUDE database, the characteristics of adverse events were summarized. The safety factors of dental instruments and equipments were discussed, to provide effective information for the safe use of medical device.