Events

Avis De Sécurité sur PROXIMATE® PPH PROCEDURE FOR PROLAPSE AND HEMORRHOIDS SET

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2010(07)
  • Date
    2010-07-16
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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
  • Notes / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Model Number PPH03 Batch Number F4N12N
  • Description du dispositif
    Counterfeit PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA