3.A retrospective analysis of 1028 adverse events of medical device reports.
Chinese Journal of Medical Instrumentation 2013;37(6):447-450
OBJECTIVETo provide suggestion for MDAEs monitoring with analyzing the features of the 1028 reports of MDAEs.
METHODSWith retrospective case study, this paper analyzed 1 028 MDAE reports in Guiyang during 2012.
RESULTSThe intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. Monitoring consciousness of grassroots users needs to be improved. The quality of the reports should be enhanced.
CONCLUSIONSMore attention should be paid to monitoring on IUD. The level of MDAEs monitoring should be improved through carrying out targeted training and publicity, establishing and improving MDAEs monitoring network.
Equipment Safety ; Intrauterine Devices ; adverse effects ; Product Surveillance, Postmarketing ; Retrospective Studies
Result Analysis
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