Medical Device Adverse Events Primary Analysis on Esophageal Stents
10.3969/j.issn.1671-7104.2017.01.013
- VernacularTitle:食道支架的可疑不良事件分析
- Author:
Yao LI
1
;
Xinmin WANG
;
Rongrong BIAN
;
Jun SUN
;
Min ZHAO
Author Information
1. 江苏省药品不良反应监测中心
- Keywords:
esophageal stents;
medical device adverse events monitoring;
risk factor;
analysis
- From:
Chinese Journal of Medical Instrumentation
2017;41(1):48-50,62
- CountryChina
- Language:Chinese
-
Abstract:
Objective To probe into the characteristics and influencing factors of ADR cases induced by Esophageal stents, so as to provide effective resolutions for safety use. Methods By retrieving published MDR cases induced by Esophageal stents in FDA MAUDE database and CNKI database, 153 cases of adverse events in MAUDE database from 2012 to 2015 and 96 valid documents between 1994 and 2015 were obtained, screened and analyzed retrospectively. Results The main MDR performance were gastrointestinal bleeding, chest pain, foreign body sensation, etc, due to the risk inherent in the product or risk during use. Conclusion The public safety of Esophageal stents use can be ensued according to perfecting related laws, establishing and regulating the MDR monitor system and strengthening the responsibility of authority, manufacturers, suppliers and medical institutions.
