OBJECTIVETo investigate the risk factors of vaginal dilators by 567 adverse event reports, and to provide a reference for the reasonable use.

METHODSWith retrospective case study, analyzed 567 reports induced by vaginal dilators by National Adverse Drug Reaction Monitoring Center in 2012.

RESULTSExpected treatment of disease might be relevant with severity of adverse events, while age was not the related factor; the influencing factor of consequences of grading was the classification of the cause of adverse events.

CONCLUSIONMonitoring should be strengthen in order to reduce or avoid the vaginal dilator adverse events.

Adverse Drug Reaction Reporting Systems ; Dilatation ; adverse effects ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Female ; Humans ; Retrospective Studies ; Risk Factors ; Vagina ; pathology