Events

Notificaciones De Seguridad De Campo acerca de Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES. Product Lot: LT300

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por N/A.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2012(05)
  • Fecha
    2012-06-18
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-ethicon-endo-surgery-(ees)-ligaclip-extra-ligating-clip-cartridges&id=607ff825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The supply and use of counterfeit ligaclip® extra ligating clip cartridges that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB advises that:  • All products in your possession should be checked using the details above to  assess whether the product is genuine or counterfeit.  • If from your assessment, you determine or suspect that you have product that  is counterfeit; identify, locate and quarantine all products to ensure it will not  be used.  • Contact your local EES representative, as EES may be able to determine if the  product is authentic.  • If it is determined to be counterfeit, advise the IMB immediately that you  have identified counterfeit products by emailing devicesafety@hpra.ie.

Device

Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES. Product Lot: LT300
  • Modelo / Serial
  • Descripción del producto
    Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA