Events

Retiro De Equipo (Recall) de PROXIMATE PPH hemorrhoidal circular stapler

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 Ethicon.

¿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
    2007-04-10
  • 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-agrafeuse-circulaire-hemorroidaire-de-la-societe-ethicon
  • 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    The company ETHICON has withdrawn from the market on April 4, 2007 the lots specified in the message in the appendix of the medical device called "PROXIMATE PPH hemorrhoidal circular stapler" reference PPH03 following a risk of migration of the glue used to glue the outer shell into the system staple guide, which may cause the surgeon to prematurely interrupt his operation, which would result in the incomplete formation of the staple line. The company has directly notified the recipients of the incriminated lots by means of the enclosed message validated by Afssaps (04/04/2007) (65 KB) This information is addressed to the directors of health establishments and correspondents materiovigilance premises for dissemination, where appropriate, to the departments concerned The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

PROXIMATE PPH hemorrhoidal circular stapler
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon