Events

Alerta De Seguridad para Trade name: Viscoelastic solution Ixium Technical name: Viscoelastic solution Ixium Registration number ANVISA: 80102510708 Hazard class: III

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; LCA S.A..

¿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
    2260
  • Fecha
    2017-04-11
  • 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
    VR Medical has no records of complaints of the products in recall, but recommends that the professionals monitor patients who have undergone procedures with those products and inform VR Medical immediately if any adverse reactions or complaints are reported through the contacts to follow: contato@vrmedical.com.br - SAC: 08007703661 Telephone: (11) 3885-7633
  • Causa
    Vr medical began to collect the products of the manufacturer lca sa registered in brazil by our company upon receipt of the anvisa notification no. 23-123 / 2016-cprod / gipro / ggfis (manufacturer was rejected during international certification of good practices for not meet the requirements established in brazilian health legislation).
  • Acción
    Field Action Code Notif 23-123 / 2016 ANVISA triggered under the responsibility of the company VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will collect.

Device

Trade name: Viscoelastic solution Ixium Technical name: Viscoelastic solution Ixium Registration ...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; LCA S.A.
  • Source
    ANVSANVISA