Alerta De Seguridad para KNEE KNEE FOR TRACHEOSTOMY WITH BALLOON SHILEY MALLINCKRODT. Affected models: 8LPC and 8FEN. Registro Anvisa n ° 10139810076. Lots affected: consult http://portal.anvisa.gov.br/wps/wcm/connect/b285ed004c0c8c7b90e6d0dc39d59d3e/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 MALLINCKRODT DO BRASIL LTD.

¿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
    1151
  • Fecha
    2012-07-20
  • 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
    According to Mallinckrodt's information, the problem in question has the potential to cause serious adverse events, because in the event of a cannula leak ventilation to the patient can be seriously compromised. Additional information available at: http://portal.anvisa.gov.br/wps/wcm/connect/cf361b004c0c8ca390efd0dc39d59d3e/Messaje+de+Alerta.pdf?MOD=AJPERES #### UPDATE (25/09/2012): A company sent a field action monitoring report, reporting that it has collected 556 product units so far, out of a total of 6,982 units marketed in Brazil. #### UPDATE (11/30/2012 and 1/30/2013): The company sent monitoring reports with information similar to previous monitoring reports (556 units collected, out of a total of 6,982 units marketed). #### UPDATE (03/28/2013): The second most recent monitoring report, the company reported that it has collected 655 product units so far.
  • Causa
    Possibility of leakage or disconnection between the inner and outer cannulae.
  • Acción
    Mallinckrodt is collecting the affected lots. Identify affected products in use and replace them as soon as possible with clinically appropriate products. If this substitution is not possible, increase the patient's direct observation frequency to monitor any problems. Check your inventory and segregate the affected products by identifying them to avoid their use. Fill out and return the Customer Return Form to Mallinckrodt Ltda. If necessary, please contact the company for additional information on how the products collected should be forwarded. Customer Return Form available at http://migre.me/9YCbV (shortened).

Manufacturer