Events

Retiro De Equipo (Recall) de PROLENE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Q-Med Corporation.

¿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
  • ID del evento
    27613
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0246-04
  • Fecha de inicio del evento
    2003-10-30
  • Fecha de publicación del evento
    2003-12-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30178
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Mesh, Surgical, Polymeric - Product Code FTL
  • Causa
    This wholesaler may have distributed some prolene mesh counterfeit product with the ethicon trademark.
  • Acción
    The firm e-mailed a Recall Notification Letter to the three wholesalers on 10/30/03 and also had telephone conversations with each of them concerning the recall. Their letter advises the accounts to subrecall down to the healthcare professional user level and also to quarantine suspect product. They also state: 'You should return any prolene mesh product to us if you are unsure whether the product you bought from us is authentic or counterfeit. '

Device

PROLENE
  • Modelo / Serial
    The firm found in their inventory codes listed in the Ethicon notice of lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed to three wholesalers in Virginia and one in Illinois.
  • Descripción del producto
    Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: www.ethicon.com
  • Manufacturer
    Q-Med Corporation

Manufacturer

Q-Med Corporation
  • Dirección del fabricante
    Q-Med Corporation, 3801 SW 30th Ave, Ft Lauderdale FL 33312-6819
  • Source
    USFDA