Events

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

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
    2008-02-07
  • 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/rappel-de-lots-d-agrafeuse-circulaire-hemorroidaire-proximate-pph-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
    On 06/02/08, the company ETHICON withdrew the lots C4FF4Y; C4FW34; C4G23W; C4FW0M; C4G001; D4G986; C4FW0N; C4G06R; D4GD5R of the PPH03 reference of the medical device called PROXIMATE® PPH Hemorrhoidal Circular Stapler. These batches were put on the market after a first recall in April 2007. This first recall was made following a risk of migration of the glue used to glue the outer shell in the guide system staples , may push the surgeon to prematurely interrupt his action, which would result in the incomplete formation of the staple line. The company ETHICON has directly notified the recipients of the incriminated lots with the message attached (06/02/2008) (33 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

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

Manufacturer

Ethicon