Events

Alerta De Seguridad para STERILE SURGICAL KIT TECNYL OVER GENERAL USE, Registration nº 10366900027, lots: T00380, T00271, T01471, T01297

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VENKURI INDÚSTRIA DE PRODUTOS MÉDICOS 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
    1280
  • Fecha
    2013-08-01
  • 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
    According to the manifestation of the company there are risks to the user because it is a sterile product with bacterial, hypoallergenic barrier.
  • Causa
    The company holding the registration identified that the product was marketed with the registration number due. according to the manufacturer the product is sterile and has been produced to the correct specifications, but there is an updated record for this product today (registration no. 10366900045).
  • Acción
    The company that owns the registration in Brazil is collecting the product.

Device

STERILE SURGICAL KIT TECNYL OVER GENERAL USE, Registration nº 10366900027, lots: T00380, T00271, ...

Manufacturer

VENKURI INDÚSTRIA DE PRODUTOS MÉDICOS LTDA