MAUDE数据库中速即纱不良事件报告分析

目的通过对美国FDA MAUDE数据库2008年1月1日至2012年11月10日速即纱(Surgicel)不良事件情况进行统计分析,分析其不良事件特点。为进一步开展可吸收止血纱布监测工作提供有力技术支持。方法对收集到的52份报告进行统计分析,初步探讨速即纱安全性。结果速即纱不良事件临床表现主要以感染、不完全吸收和过敏反应居多,可能原因为纱布自身物理特性、患者自身体质、手术环境及无菌操作技术等。结论重视可吸收止血纱不良事件监测工作,加强对监测数据的分析与利用,为公众用械安全提供保障。

Analysis of Adverse Event Reports of Surgicel in MAUDE Database

Objective By analyzing the adverse everts of Surgicel which were collected from FDA MAUDE database on January 1,2008 to November 10,2012 and the characteristics of the adverse events,to provide strong technical support for the further development of adverse events of Surgicel monitoring work.Methods Statistically analyzed the collected data and discussed the safety of Surgicel.Results The manifestations of adverse events mainly included infection,incomplete absorption and allergies,possibly associated with material factor,patients factor and use factor.Conclusion By paying more attention to adverse events of absorbability hemostatic gauze,strengthening the analysis and utilization of the monitoring database,to provide effective information for the safe use of the medical device.