Risk Analysis and Study of Post-marketing Adverse Events for Absorbable Sutures.
10.3969/j.issn.1671-7104.2023.05.020
- Author:
Yan WU
1
;
Xiaoqing SUN
1
;
Xuelei GONG
2
;
Dong LI
3
;
Ye ZENG
1
;
Jianbing YIN
1
Author Information
1. Center for Medical Device Adverse Events Monitoring of Zhejiang, Hangzhou, 310009.
2. Yunnan ADR Monitoring Center, Kunming, 650106.
3. Center for Drug Reevaluation, NMPA, Beijing, 100022.
- Publication Type:Journal Article
- Keywords:
absorbable suture;
adverse events;
medical device;
risk
- MeSH:
Humans;
Sutures/adverse effects*;
Risk Assessment;
Risk Factors
- From:
Chinese Journal of Medical Instrumentation
2023;47(5):571-575
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate, analyze, and evaluate the risk data associated with the clinical use of absorbable sutures by retrieving and summarizing information from the databases of the US FDA and CNKI, as well as the adverse event reports related to absorbable sutures from January 2019 to October 2022 within Zhejiang province. The adverse event reports are obtained from both incident locations and monitoring organizations affiliated with the registrant. The aim is to identify the main risk factors associated with the clinical use of absorbable sutures. The key risk factors are potential product quality defects, product design and material selection, clinical selection and application, and postoperative recovery care including patient's self-care. Risk control strategies are further proposed to reduce or minimize the risk of adverse events caused by this product.
