医疗器械不良事件是指获准上市质量合格的医疗器械在正常使用情况下发生的、导致或可能导致人体伤害的各种有害事件[1]。2012年朝阳市共收到并上报可疑医疗器械不良事件报告431例,每百万人口平均病例报告数127例。为更好地推进朝阳市医疗器械不良事件监测工作,提高医疗器械不良事件监测信息利用,现对2012年上报的431例医疗器械不良事件报告进行统计分析。 Medical device adverse events refer to the various harmful events that may or may cause harm to human beings in the normal use of medical devices that have been approved for public listing. In 2012, a total of 431 cases of suspected medical device adverse events were reported and reported in Chaoyang City, with an average of 127 cases per million inhabitants. In order to better promote the monitoring of medical device adverse events in Chaoyang City and improve the utilization of monitoring information of adverse medical device events, a statistical analysis was made on 431 medical device adverse event reports reported in 2012.