Events

Retiro De Equipo (Recall) de Composix Kugel Large Wall Repair Implants

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por BARD France.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2006-04-07
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-implants-de-refection-de-paroi-bard-composix-kugel-large
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    The company Bard France has withdrawn from the market on 05 April 2006 the references and lots specified in the recall message of the medical device called "Bard Composix Kugel Large Wall Repair Implants" following several cases of rupture of the ring. The company has directly notified the recipients of the incriminated lots with the message attached (05/04/2006) (48 KB) validated by the Afssaps. This information is addressed to the directors of health facilities and to the local correspondents for material vigilance for dissemination, where appropriate to the services concerned. The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

Composix Kugel Large Wall Repair Implants
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    BARD France

Manufacturer

BARD France