Abstract: Objective By analyzing the reports on adverse events of surgical suture devices in Hunan province in 2010, provide technical support for the monitoring work of medical device adverse events. MethodsWith the description method, statistically analyze 409 reports collected in 2010 with the help of Microsoft Excel, primarily discuss the existing problems and present corresponding measures. ResultsThese surgical suture adverse events in Hunan province largely occurred in the patients between 20-30 years old. The reports mainly came from medical facility, and most events happened in November, in which the majority was absorbable surgical suture adverse events. The clinical manifestations of adverse events focused on suture reaction and poor wound healing, 80.20% of all the adverse events needed internal and surgical treatment to avoid the permanent injury. ConclusionWe should strengthen the training of surgical suture adverse event monitoring, promote the quality of reports to make them become effective information available for the safe use of medical devices.

Key words: surgical suture, adverse events, devices, analysis