[Statistic analysis of 1900 adverse events of medical device reports].
OBJECTIVE
Provide the suggestion for MDAEs monitoring and the reference to strengthen the medical device administration by analyzing the 1900 reports of MDAEs.


METHODS
With retrospective case study, analyze 1900 MDAE reports in Henan province in 2008. RESULT Orthopedic implants and the intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. The scope that the reports covered needs to be raised.


CONCLUSIONS
Further focus monitoring on orthopedic implants and the IUD should be strengthened. The medical device adverse events monitoring should be promoted by improving regulations, training and publicity.
Lianying
Sun
S
Henan center for ADR monitoring, Henan, Zhengzhou, 450004. hnypbzsqx@126.com
Sikang
Xu
X
D004868:Equipment Failure / Q000706:statistics & numerical data*; D007434:Intrauterine Devices / Q000009:adverse effects; D019736:Prostheses and Implants / Q000009:adverse effects; D012189:Retrospective Studies