Alerte De Sécurité sur durex polyisoprene synthetic latex condoms

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Reckitt Benckiser.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-07-20
  • Date de publication de l'événement
    2018-07-30
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: durex polyisoprene (pi) synthetic latex condoms medical device manufacturer, reckitt benckiser, has issued a medical device safety alert concerning its durex polyisoprene (pi) synthetic latex condoms. the manufacturer recently found that a small number of pi synthetic latex condoms made earlier this year are not passing its stringent quality tests. according to the manufacturer, the tests have shown that while all pi synthetic latex condoms which are currently on the market in all countries are expected to be above the international quality standard (iso 23409:2011) for male condoms of this type, recently a small number of condom batches did not pass retesting against the more stringent quality standard. there have been no adverse events reported in relation to any of these batches of condoms and there is no immediate safety concern for consumers, and the issue does not present a significant or unacceptable risk. product recall is on-going. according to the local supplier, the events do not impact any pi synthetic latex condoms, namely durex real feel condoms, that are marketed in hong kong. all batches of durex pi synthetic latex condoms sold in hong kong have been retested and stress tested and continue to meet the stringent quality requirements for quality. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 july 2018.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Durex polyisoprene (PI) synthetic latex condoms
  • Manufacturer

Manufacturer