Events

Alerte De Sécurité sur CIDEX OPA Solution

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

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
    2015-08-19
  • Date de publication de l'événement
    2015-08-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150820.html
  • 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: advanced sterilization products cidex opa solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex opa solution. the affected product code numbers are 20391 and 20490. the manufacturer conducted a post-market surveillance review of two international complaints for anaphylaxis following medical procedures involving a device disinfected with cidex opa solution. subsequent investigation identified the user failed to follow the rinsing instructions to remove residual cidex opa solution from the medical devices post-processing. improper rinsing may result in the potential for anaphylaxis risk for patient populations beyond bladder cancer patients. the manufacturer advises customers that they may keep their current inventory of cidex opa solution and continue to safely use the product in accordance with the instructions for use, which contain the rinsing instructions. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 august 2015.

Device

CIDEX OPA Solution
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products