Panorama of notifications about adverse events and technical complaints related to facemasks
DOI:
https://doi.org/10.22239/2317-269x.01930Keywords:
Facemasks, Adverse Events, Product Health Surveillance, PandemicAbstract
Introduction: In the daily routine of Health Professionals, mainly in the midst of the Sars-CoV-2 pandemic, facemasks are important devices; however, there is no post market control for these products. Objective: Evaluate the Adverse Events (AE) and Technical Complaints (TC) related to facemasks and respirators, to list and categorize the public health problems involving these products. Method: Cross-sectional, descriptive, retrospective and documental study with a quantitative approach, including data from January 2010 to May 2020 available in the Notivisa system. The analyzed data had national coverage and were reclassified, when necessary, according to their category (EA or QT). Results: 443 notifications were included in the study containing 519 claims (AE and TC). The data distribution on the analized decade presented an accentuated decrease; the Southeast region had the highest prevalence of claims in Brazil. Most of the notifying companies were health establishments and the highest prevalence of health events found were Adverse Events that affected the user when fixing strips and nose clips (such as detachment of the nose clip and breaking of the fixation straps during use), indicating serious biosecurity problems. Conclusions: This study characterized the Adverse Events and the Technical Complaints in facemasks focusing on health promotion and indicating the necessity of sanitary monitoring improvement of the products.
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Author Biographies
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Rafael Christian de Matos, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brasil
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Adriane Zacarias Nunes , Fundação Ezequiel Dias, Instituto Otávio Magalhães, Belo Horizonte, MG, Brasil
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Elisângela Alves Silva, Fundação Ezequiel Dias, Instituto Otávio Magalhães, Belo Horizonte, MG, Brasil
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Edilânia Castro Dias, Fundação Ezequiel Dias, Instituto Otávio Magalhães, Belo Horizonte, MG, Brasil
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Ramon da Silva Dutra, Fundação Ezequiel Dias, Instituto Otávio Magalhães, Belo Horizonte, MG, Brasil
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Aline Magalhães de Matos da Silveira, Fundação Ezequiel Dias, Instituto Otávio Magalhães, Belo Horizonte, MG, Brasil
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Copyright (c) 2022 Rafael Christian de Matos, Adriane Zacarias Nunes, Elisângela Alves Silva, Edilânia Castro Dias, Ramon da Silva Dutra, Aline Magalhães de Matos da Silveira
This work is licensed under a Creative Commons Attribution 4.0 International License.
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