Events

Field Safety Notices about PROXIMATE® PPH PROCEDURE FOR PROLAPSE AND HEMORRHOIDS SET

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2010(07)
  • Date
    2010-07-16
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    "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."
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Model Number PPH03 Batch Number F4N12N
  • Product Description
    Counterfeit PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA