Events

Alerta De Seguridad para Trade name: NITINOL CORDIS STENTS Technical name: STENT FOR PERIPHERAL ARTERIES ANVISA registration number: 80145901077 Hazard class: IV Model affected: PC0540XCE; PC0620XCE; PC0630XCE; PC0640XCE; PC0720XCE; PC0730XCE; PC0830XCE; PC0840XCE; PC0920XCE; PC0930XCE; PC0940XCE; PC1020XCE; PC1030XCE; PC1040XCE

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    2028
  • Fecha
    2016-12-13
  • 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
    Based on recent complaints and subsequent investigation, the company detected that products manufactured between april 27, 2015 and november 22, 2015 are associated with an increase in the frequency of incidents of difficulty of placement and in some cases separation of the rod of the external limb resulting in the impossibility of implanting the stent or in the possibility of partial placement of the stent.
  • Acción
    Field Action Code 16000079 triggered under the responsibility of Johnson & Johnson of Brazil Ind. And Com. De Prod. for Health Ltda. Company will collect for further destruction of the product.

Device

Trade name: NITINOL CORDIS STENTS Technical name: STENT FOR PERIPHERAL ARTERIES ANVISA registrati...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.