| ABSTRACT Objective:To investigate the risk factors of gynecological ozonic therapeutic instrument by 136 adverse event reports, and to provide a reference for the reasonable use. Methods:With retrospective case study, analyzed 136 reports induced by gynecological ozonic therapeutic instrument by National Adverse Drug Reaction Monitoring Center from January 1, 2010 to June 30, 2015.Results:There were 99 cases of adverse events clearly associated with the use of Ozonic Therapeutic Instrument, the patients’ age range was 18 58 years old. The cases mainly reported by equipment use enterprises, accounting for 75.74%. The delay treatment by instrument failure was the most common adverse event performances, according for 57.58%, respectively. Adverse events might be relevant to the risk factors of product quality, technical operation, patient’sspecificity and instrument disinfection. Conclusion:We should strengthen the monitoring and risk control in order to reduce the gynecological ozonic therapeutic instrument adverse events, maintain the public use machinery safety. |
