Risk analysis for coil adverse events based on FDA MAUDE database
10.19745/j.1003-8868.2025110
- VernacularTitle:基于FDA MAUDE数据库的弹簧圈不良事件风险分析
- Author:
Jian-wei YANG
1
;
Lin HUANG
;
Yu-juan ZHAO
;
Yi XUAN
;
Jian-jun CAO
;
Chang-qing LIU
;
Hui-fang NIU
;
Xia LI
Author Information
1. 山东省药品不良反应监测中心,济南 250011
- Publication Type:Journal Article
- Keywords:
coil;
adverse event;
FDA Manufacturer and User Facility Device Experience(MAUDE)database;
risk analysis
- From:
Chinese Medical Equipment Journal
2025;46(6):83-87
- CountryChina
- Language:Chinese
-
Abstract:
The coil adverse events in the U.S.Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database from January 2021 to June 2024 were analyzed retrospectively.The risks of coils during the clinical application and their causes were explored with hospital survey and expert demonstration in Shandong Province.Some improving measures were put forward for the safe use of coils,including implementing the main responsibility of the registrant,enhancing the professional skills of the using institutions and strengthening the supervision of the supervisory authorities.[Chinese Medical Equipment Journal,2025,46(6):83-87]
