Events

Alerta De Seguridad para Electro-Hemostasis Catheter Disposable Bipolar GOLD PROBE. Reg. Anvisa: 10341350350. Lots Affected: See annex Letter to the Clients (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/954_carta.pdf).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda..

¿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
    954
  • Fecha
    2009-02-03
  • 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
    Boston Scientific do Brasil Ltda has already started collecting the product. The problem was detected by Boston Scientific Corporation during a quality inspection performed by the company. The Technovigilance Unit is following up on this case.
  • Causa
    The packaging tray of some units may be broken, which compromises the sterile barrier of the product. if used, the potential effect for the patient may be infection.
  • Acción
    Users of the product in question shall: (1) Immediately discontinue use and segregate the collected product; (2) Complete the Verification and Traceability Response Form; (3) Pack / send the affected product. To access the Form of Traceability provided by the company: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/954_formulario.pdf.

Device

Electro-Hemostasis Catheter Disposable Bipolar GOLD PROBE. Reg. Anvisa: 10341350350. Lots Affecte...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA