Events

Alerte De Sécurité sur Alterna® Sterile Post-Operative ostomy bags

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

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
    2011-07-28
  • 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/press_20110728.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
    Press release
  • Cause
    Recall of alterna® sterile post-operative ostomy bags due to sterility problem after assessing a notification from a local medical device supplier, coloplast (hong kong) ltd, about its proposal to recall one of its product alterna® sterile post-operative ostomy bag from consumers on sterility ground, the department of health (dh) endorsed the action. coloplast, the manufacturer of the device under recall, found during routine product sterility test that a lot has failed. investigation reveals that the failed lot of product was sterilised after january 2010, when the sterilisation process was moved over to a new site. thus, coloplast decided to conduct a recall of all products sterilised at the new site, though no report of any adverse incident arising from the use of ostomy bags produced in the new site has been received worldwide. dh also had not received any such notification locally. the models under recall are 12808, 12810 and 12818, all with expiry date on january 1, 2013 or later. alterna® sterile post-operative ostomy bag is used for collecting output from stoma - an opening created on the abdomen after bowel or urinary tract surgery in order to divert faeces or urine respectively. a spokesman for dh said, "since there is concern over the sterility of the product, with potential risk of infection, the department endorses coloplast (hong kong) ltd's recall as a measure to safeguard public health." coloplast (hong kong) ltd's sales record showed that its products have been sold to both hospitals and patients here in hong kong. "customers who have the affected products in hand should return them to coloplast (hong kong) ltd. the company can be reached through its hotline at telephone number 3628 7436. people who have used the products should also consult their healthcare professionals if feel unwell or in doubt," the spokesman advised. dh had already alerted the hospital authority, private hospitals, relevant healthcare institutions and medical associations about the matter, and will closely monitor the recall besides continuing investigation. ends/thursday, july 28, 2011 issued at hkt 20:58.

Device

Alterna® Sterile Post-Operative ostomy bags
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of Alterna® Sterile Post-Operative ostomy bags due to sterility problem
  • Manufacturer
    Coloplast

Manufacturer

Coloplast