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德国联邦药品和医疗器械管理局(BfArM)分析了2016年医疗产品的不良器械事件报告。

2016年共有11976份报告,2015年有10306份。

在2016年,5975份报告与有源医疗器械相关,5217份报告涉及非有源医疗器械,784份涉及体外诊断医疗器械

不良器械事件报告涉及最多的产品是有源植入性医疗器械,针对其的报告有3464份,其次是非有源植入性医疗器械,针对其的报告有2637份;注射用品、输液、输血和透析产品的报告有1815份;涉及手术设备和麻醉的报告有775份;以及544份报告与人体医学器械相关。

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