Retiro De Equipo (Recall) de Mona Lisa CuT 380A QL

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 HRA Pharma.

¿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
    2009-02-20
  • País del evento
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
  • 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 19/02/09, the company HRA Pharma withdrew from the market lot 2007E04A (expiry 05/2011) of the intrauterine medical device Mona Lisa CuT 380A QL following claims describing, due to a manufacturing defect, the impossible passage of the intra-uterine device through the insertion tube, thus preventing its insertion in the patient. The users concerned were informed by the laboratory, directly from the attached messages (20/02/2009) (96 ko ) or by general distribution to wholesalers / pharmacies and pharmacies of health establishments (20/02/2009) (97 KB). This information is addressed to the directors and correspondents of materiovigilance of the health establishments for diffusion if necessary to the services concerned, to the gynecologists of town, to the centers of maternal and infant protection and to the general councils concerned, to the wholesale distributors and pharmacists of town.

Device

  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    LAANSM