252例宫内节育器不良事件分析  

Analysis on 252 Cases of Intrauterine Device Adverse Events

作　　者：吴晓渊[1,2] 王萍[3] 程云章[1] 

机构地区：[1]上海理工大学,上海200093 [2]南通市食品药品监督管理局,南通226005 [3]南通大学医学院,南通226006

出　　处：《中国医疗器械信息》2015年第1期45-48,共4页China Medical Device Information

摘　　要：目的:对宫内节育器的避孕机理和不良事件发生原因进行探讨,为安全使用该医疗器械提供参考。方法:对国家医疗器械不良事件监测数据库中252例宫内节育器不良事件进行分析。结果:导致不良事件发生的原因主要有患者因素、器械因素、操作因素。结论:正确选择宫内节育器的规格型号和材料,加强术后随访,进一步研发新材料,能够减少其不良事件的发生。Goals： In order to use the medical instruments safely, we investigate the contraception mechanism and the causes of adverse events in the use of intra - uterine device.Methods： We analyze the 252 cases adverse events of intra - uterine device from the database of national medical devices vigilance.Results： The main causes of adverse events are patient factors, device factors and operating factors.Conclusion： For the purpose of reducing the adverse events, one needs to choose the appropriate intra - uterine device of right size, model and material, to enhance post-surgery folow-up visits, and to research and develop new materials.

关 键 词：宫内节育器 不良事件 避孕 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]