Abstract: 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.

Key words: absorbable hemostatic gauze, Surgicel, medical devices adverse events, analysis