Chinese Journal of Pharmacovigilance ›› 2010, Vol. 7 ›› Issue (9): 542-546.

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The Integrity Analysis of Suspicious Medical Device Adverse Event Reporting Form

NUERJIANG·shabukai1 ,YU Yong-qiang1 ,JIANG Dong -gui2, ZHU Shu -bing3 ,GUO Xue4   

  1. 1.Adverse Drug Reaction Monitoring Center of Xinjiang Uygur Autonomous Region, Xinjiang Urumchi 830002, China;
    2.Hunan Center for Drug Reevaluation and ADR Monitoring,Hunan Changsha 410013, China;
    3.Chongqing Center for Adverse Drug Reaction Monitoring, Chongqing 400014,China;
    4.National Center for Adverse Drug Reaction Monitoring, Beijing 100045, China
  • Received:2009-09-03 Revised:2016-03-09 Online:2010-09-08 Published:2016-03-09

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Abstract: Objective To bring Methods and make suggestions for the quality of suspicious Medical Device Adverse Event(MDAE )reports, we statisticed, analysised and evaluated all suspicious MDAE reports from 2002,Jan.1st to 2008, Dec.31th. Methods 2 166 reports were randomly sampled from the database of National Center for ADR Monitoring, Excel and SPSS statistical software package were used to analysis the loss rates after adopting these reports. The contents of 2 166 reports were compared with the current international reports. Results &Conclusion This study adopted randomly sample, and sample rate was 5%, so the representative of samples was better, and the method was sensitive, and the Conclusion was credible. The statistically significant deficiencies in total 39 accounts for 88.6% of the total number of items. This study indicated that the firstly loss rate was coming from using department, mainly including study de-partment's name and reporter's occupation. The secondly loss rate was coming from management corparation or manufacture corparation. At present, there were many deficiencies of Chinese MDAE reports, the reports' quality should be further enhanced.

Key words: Suspected Medical Device Adverse Event, report, item, loss rate

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