Events

Alerta De Seguridad para BLAKE / J-VAC Silicone Drains (Anvisa Registry: 80145900995); Silicone Drains with Trocarte BLAKE / J-VAC (Registro Anvisa: 80145901014); J-VAC Drainage System (Anvisa Record: 10132590602). See list of affected lots at http://portal.anvisa.gov.br/wps/wcm/connect/bf9d8f0046a11aa69f919fc9c474c85c/Lotes+afetados.pdf?MOD=AJPERES

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 Medical Brasil 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
    1054
  • Fecha
    2011-04-25
  • 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 Johnson & Johnson Medical Brazil Ltda, the sterile barrier of the products may have been damaged and there is a possibility that the use of these products may result in the introduction of pathogens into patients. According to the company, this may not be clinically significant or may lead to a clinical picture of infection, which in itself may be of limited clinical significance or may result in serious injury or death.
  • Causa
    Potential impairment of the sterile product packaging barrier.
  • Acción
    Users of the cited products shall (1) verify their stock and immediately discontinue use of the affected products and lots; and (2) Report Johnson & Johnson Ltd. on affected products located in stock, following the instructions provided by the company (see http://portal.anvisa.gov.br/wps/wcm/connect/d057c60046a118569f609fc9c474c85c/Carta+ to the + user% C3% A1.pdf? MOD = AJPERES).

Device

BLAKE / J-VAC Silicone Drains (Anvisa Registry: 80145900995); Silicone Drains with Trocarte BLAKE...

Manufacturer

Johnson & Johnson Medical Brasil Ltda.