Adverse events of low frequency electromagnetic comprehensive therapy apparatus:24 cases analysis / 中国基层医药

ABSTRACT

Objective To perform statistical analysis of low frequency electromagnetic comprehensive therapy apparatus for adverse events,and the characteristics of the adverse events,and investigate the risk factors,thus to provide effective information for the safe of the medical device.Methods Using database software from national MDR monitoring center,preliminary study on safety of low frequency electromagnetic comprehensive therapy apparatus was performed.Results The manifestations of adverse events was 50.0%,mainly included skin allergy and scald,burn, stabbing pain,25.0% included treatment without feeling,parts damaged,other manifestations accounted for 25.0%. Conclusion Monitoring should be strengthened in order to reduce or avoid the vaginal dilator adverse events.