Alerta De Seguridad para (1) INTERMEDIATE HEAD INCOMEPE (FEMALE HEAD), DIAMETERS 39mm, 41mm, 43mm, 45mm, 47mm, 49mm, 51mm and 53mm (product without registration in Anvisa); (2) ACETÁBULO MULLER INCOMEPE, DIAMETER 42mm (product without registration in Anvisa); and (3) INCOMEPE INTERCHANGEABLE HEAD (FEMALE HEAD), DIAMETERS 22mm, 26mm, 28mm AND 32mm - Anvisa registration n ° 10395270017.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Incomepe Indústria de Materiais Cirúrgicos 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
    1213
  • Fecha
    2012-12-13
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    The irregularities were detected by Anvisa on inspection carried out at the company. For additional information, access copy of RE No. 4,063 of 09/27/2012. The company has already started the process of collecting the products.
  • Causa
    Commercialization of products not registered in anvisa (products 1 and 2) and modification of specification without authorization of anvisa (product 3).
  • Acción
    Suspension of manufacture, disclosure, distribution, trade and implantation of the aforementioned products and collection, of all units of the aforementioned products available on the market, by Incomepe Indústria de Materiais Cirúrgicos Ltda.

Manufacturer