Alerta De Seguridad para BARDPORT TOTALLY IMPLANTABLE IN PLASTIC AND SILICONE - Registration: 10178010192 - Hazard Class: IV - MAXIMUM RISK

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por POLITEC IMPORTAÇÃO E COMÉRCIO LTDA; BARD ACCESS SYSTEMS.

¿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
    1352
  • Fecha
    2014-01-13
  • 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
    If the affected product is implanted in a patient, the manufacturer DOES NOT recommend removing the device. However, the final decision regarding this procedure should be at the discretion of the treating physician. ## UPDATE ON 9/1/2014 - COMPANY COMPLETED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##
  • Causa
    Silicone catheters of particular batches were identified with a size less than 5.3fr than the size of 6.6fr mentioned on the labeling of the product. annex: letter to customers.
  • Acción
    Company is conducting the renegotiation of affected lots. The lots REXC0931 and REXC0736 are under threat in Brazil. ## UPDATE ON 9/1/2014 - COMPANY CONCLUDED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##