Events

Alerta De Seguridad para Interface with patient of the disposable extravasation sensor, model: XDS PID Interface with patient of the disposable extravasation sensor, registration 80172899003, hazard class I, lot 30235.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medrad do Brasil, Distribuição, Importação de Equipamentos e Produtos Médicos e Serviços técnicos Ltda.; Medrad INC..

¿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
    1796
  • Fecha
    2015-01-13
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    There is no risk of using the product once the customers have received the requested product.
  • Causa
    Identified absence of the nationalization label on the product being distributed.
  • Acción
    Gathering and destruction. Action code: 2015 / DEV / 017692. The company directs customers to verify the presence of the product in the company's stock. If identified, discontinue use and segregate. The customer must contact the company so that a product recall and replacement authorization is generated.

Device

Interface with patient of the disposable extravasation sensor, model: XDS PID Interface with pati...

Manufacturer

Medrad do Brasil, Distribuição, Importação de Equipamentos e Produtos Médicos e Serviços técnicos...
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    ANVSANVISA