Events

Alerta De Seguridad para Trade Name: GORE-TEX VASCULAR GRAFTS; registration: 80067930035; class of risk: IV ///// Trade Name: GORE INTERING VASCULAR RUBBER; registration: 80067930023; class of risk: IV ////// Trade Name: GORE HYBRID VASCULAR PROSTHETIC; registration: 80067930034; class of risk: IV ///// Trade Name: GORE-TEX STRETCH VASCULAR GRAFTS; registration: 80067930024; class of risk: IV ///////// Trade Name: GORE VIATORR TIPS ENDOPROTHESES; registration: 80067930029; class of risk: IV ///// Trade Name: GORE VIABAHN ENDOPROSTHESIS; registration: 80067930020; class of risk: IV

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por W.L. GORE & ASSOCIATES DO BRASIL LTDA.; W.L. Gore & Associates, 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
    1854
  • Fecha
    2016-04-12
  • 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
  • Causa
    The wl gore & associates do brasil ltda company that registered these products in october 2015 received good manufacturing practices inspection reports that had unsatisfactory results regarding 6 (six) wl gore inc plants in flagstaff. subsequently, said company received notification of the supervision of anvisa, no. 902/2015 of gfisc / ggfis / sucom / anvisa requesting the suspension of imports of all products manufactured in the 06 plants of flagstaff. 07 december 2015 was published in official gazette resolution re 3 366 of december 4, 2015 requesting the suspension of import, distribution and marketing of 07 products.
  • Acción
    Gathering affected products. Action code 002/2015.

Device

Trade Name: GORE-TEX VASCULAR GRAFTS; registration: 80067930035; class of risk: IV ///// Trade Na...

Manufacturer

W.L. GORE & ASSOCIATES DO BRASIL LTDA.; W.L. Gore & Associates, Inc.