Events

Retiro De Equipo (Recall) de ENDOPROTHESIS OESOPHAGIENNE

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 LIFE PARTNERS EUROPE.

¿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
    2007-11-16
  • 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-endoprotheses-oesophagiennes-societe-life-partners-europe
  • 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
    On 15/11/07, the company LIFE PARTNERS EUROPE has withdrawn from the market all the batches made from April 2007 of HEV and NES references of the medical device called ENDOPROTHESIS OESOPHAGIENNE, following incidents describing fractures of prostheses, occurred at at least 1 month after implantation, including one that resulted in the death of the patient. The company LIFE PARTNERS EUROPE has directly notified the recipients of the incriminated lots with the message attached (16/11/2007) (32 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the distributor.

Device

ENDOPROTHESIS OESOPHAGIENNE

Manufacturer

LIFE PARTNERS EUROPE