Events

Alerta De Seguridad para Processed and Preserved Cryogenically Transplantable Human Heart Valve. Nos. Codes: 98-0132HV-01, 98-0132HV-02, 98-0476HV-01, 98-0476HV-02, 98-1302HV-01, 98-1532HV-01, 98-1532HV-02, 99-1311HV- 99-1311HV-02.

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

¿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
    551
  • Fecha
    2002-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The valves above may have been collected from donors who have not been properly evaluated. the manufacturer initiated a correction by letter dated 16 october 2001.
  • Acción
    Make sure you have received the letter dated 16 October 2001 from LifeNet. Identify and isolate any affected product in your inventory. For more information, contact your local LifeNet representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Processed and Preserved Cryogenically Transplantable Human Heart Valve. Nos. Codes: 98-0132HV-01,...
  • Modelo / Serial
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Source
    ANVSANVISA