Abstract: Objective To investigate the general situation of MDAEs in our county, find out the regularity, and provide warning for clinical safe use of medical devices. Methods With the retrospective analysis, use Microsoft Excel to summarize and screen the collected data, make statistics, evaluation and analysis in terms of product category and main manifestations of adverse events. Results The MDAEs have no significant correlation with gender and age. Among the three types of medical devices, typeⅡand typeⅢare the monitoring subjects. Medical polymer materials and products have the largest number of reports. Implant materials and artificial organs have the maximum number of reports on injury.As for analysis of the specific variety, the number of intrauterine device adverse events is the first, the main adverse event manifestations are related to device quality and patients'allergic constitution, etc. These cases were reported mainly by doctors. Conclusion To strengthen the understanding of MDAEs risk, intensify the monitoring on key varieties, and continuously improve the medical device control and management level.

Key words: medical devices, adverse events, analysis, intensive monitoring, safe use of medical devices