Events

Avis De Sécurité sur Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms

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
    SN2005(02)
  • Date
    2005-03-14
  • 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=/durex-extra-safe-12-pack-condoms-and-durex-fetherlite-12-pack-condoms&id=639af825-9782-6eee-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 two above specified batches of condoms bearing the durex brand name are counterfeit products that do not meet the requirements of the european standard for condoms.
  • Action
    The IMB advises that you: Check both the outer packet and the condom foil to see if the details given above are the  same as those outlined on the product in your possession. If you have identified that you have product with the details above return any such affected product in your possession to your local pharmacy. If you think you may have used the affected condoms and have any health concerns, please consult your General Practitioner for their advice. Please be advised that this notice only applies to the 12 pack size of condoms specified above and not to any other pack size.

Device

Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Modèle / numéro de série
    Product Name:        Durex Extra Safe 12 Pack Condoms Batch Number:        20602503 Expiry Date:            2007/11 Product Name:        Durex Fetherlite 12 Pack Condoms Batch Number:        VR3073 U / VR3073 C / VR3073 E / VR3073 € Expiry Date:            2008/02
  • Description du dispositif
    Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA