Events

Safety Alert for RESPIRATORY PROTECTION EQUIPMENT

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1040
  • Date
    2010-12-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Notify by NOTIVISA (http://www.anvisa.gov.br/hotsite/notivisa/index.htm) for the commercialization of mask or respiratory protection equipment without registration or contact the Unit of Technovigilance (UTVIG / NUVIG / ANVISA) by email tecnovigilancia@anvisa.gov.br.
  • Reason
    Use of masks and respiratory protective equipment not registered in anvisa and manufactured and marketed by companies without operation permit - afe.
  • Action
    The Technovigilance Unit alerts to the fact that if masks or respiratory protection equipment are used for the purpose of prevention in activities that imply exposure to respiratory risks, they are characterized as medical products and are therefore subject to registration with ANVISA, in accordance with Resolution RDC 185/2001. Thus, the acquisition and use of these products without registration in ANVISA constitutes a sanitary irregularity and its manufacture and commercialization represent sanitary infraction. The granting of registration of medical product is a prerogative of the National Agency of Sanitary Surveillance - ANVISA, and the company must prove, at the time of registration, its safety and efficacy according to the regulatory norms. The product registration number is on the label of the product. In case of doubts, consult the ANVISA website: (1). http://www7.anvisa.gov.br/datavisa/Authorization_Authorization/consulta_authorization_internet.asp; (2). http://www7.anvisa.gov.br/datavisa/Consulta_Produto_correlato/consulta_correlato.asp; (3). http://www7.anvisa.gov.br/datavisa/Consulta_Produto_correlato/consulta_correlato.asp; (4). http://www.anvisa.gov.br/scriptsweb/correlato/correlato_rotulagem.htm.

Device

RESPIRATORY PROTECTION EQUIPMENT
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA