Events

Alerta De Seguridad para CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See attachment at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/995_lista_produtos.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
    995
  • Fecha
    2009-11-03
  • 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
    Any distribution or use of any remaining product affected by this Voluntary Settlement must stop immediately. This Voluntary Collection does not include any product other than those of the affected lots listed in the Annex. Regulatory authorities around the world that are affected by this Voluntary Removal for Removal are being notified as required. Please carefully read the pickup instructions included with this Voluntary Referral Notification to the Customer. Your local Sales Representative can answer any questions you may have regarding this Volunteer Recruitment. More attachments at: http://www.anvisa.gov.br/tecnovigilancia/alertas/index.htm
  • Causa
    Boston scientific has concluded that the seal on the sterile packaging of the affected products may be compromised. it has been reported that the sealing of the outer pouch may be ruptured. if a compromised seal is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, sepsis, endocarditis, organ failure, and death.
  • Acción
    The necessary actions are as follows: (1) Check in your stock if you have affected products; (2) Segregate affected products by visually identifying them with a label; (3) Contact the product registration holder (Boston Scientific of Brazil) or an authorized distributor for the return of the material. The use of affected products in stock must cease immediately.

Device

CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See att...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA