Events

Alerta De Seguridad para Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Risk classification IV-Maximum Risk. Lots affected: 172 lots (description of the attached lots, next to the letter to the clients)

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; Cordis Corporation.

¿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
    1910
  • Fecha
    2016-06-14
  • 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
    Recommendations to users and patients: Check the inventory immediately to confirm if you have any of the affected lot units. Identify and separate the units of the affected lots so as to ensure that the affected product is not used. Check all the places of storage and use.
  • 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. considering the risk analysis of the product, the potential impact of the impossibility of implanting the stent or the possibility of partially implanting the stent include a delay during the procedure while a replacement device is prepared; vessel injuries requiring unplanned percutaneous or surgical intervention to prevent injury or permanent disability; or in more severe cases, transient ischemic attack or stroke.
  • Acción
    Action code 16000079. Letter to customers //// Collection.

Device

Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Ris...

Manufacturer

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