Events

Notificaciones De Seguridad De Campo acerca de PROXIMATE® PPH PROCEDURE FOR PROLAPSE AND HEMORRHOIDS SET

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
    SN2010(07)
  • Fecha
    2010-07-16
  • 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-proximate-pph-procedure-for-prolapse-and-hemorrhoids-set&id=ce92f825-9782-6eee-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 potential supply and use of a counterfeit haemorrhoidal circular stapler product called proximate® pph procedure for prolapse and hemorrhoids set, product code pph03, from the above batch that is not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB advises that:  All product 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, quarantine the product to ensure it will not be used and contact your local EES representative, JOhnson Ireland, who will be able to confirm if the product is authentic.  • If you identify that you have product that is counterfeit you should return any such affected product in your possession to  Johnson & Johnson Ireland, and inform the IMB.

Device

PROXIMATE® PPH PROCEDURE FOR PROLAPSE AND HEMORRHOIDS SET
  • Modelo / Serial
    Model Number PPH03 Batch Number F4N12N
  • Descripción del producto
    Counterfeit PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA