[A retrospective analysis of 1028 adverse events of medical device reports].

OBJECTIVE

To provide suggestion for MDAEs monitoring with analyzing the features of the 1028 reports of MDAEs.

METHODS

With retrospective case study, this paper analyzed 1 028 MDAE reports in Guiyang during 2012.

RESULTS

The 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.

CONCLUSIONS

More 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.