Alerta De Seguridad para RESPIRATORY PROTECTION EQUIPMENT

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1040
  • Fecha
    2010-12-23
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    Use of masks and respiratory protective equipment not registered in anvisa and manufactured and marketed by companies without operation permit - afe.
  • Acción
    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

  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA