Events

Alerte De Sécurité sur Multiload Radiopaque Cu375 intrauterine contraceptive devices

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Merck Sharp & Dohme (Asia) Limited.

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
    2013-03-27
  • 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_20130327.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 multiload radiopaque cu375 intrauterine contraceptive devices (with photos) the department of health (dh) today (march 26) instructed a local medical device supplier, merck sharp & dohme (asia) limited to recall one lot of multiload radiopaque cu375 intrauterine contraceptive devices (iucds), manufactured by an irish company, multilan ag, following discovery of impurities inside the packing of a number of devices. the discovery was made by dh's family health service (fhs) when they conducted routine inspection of stock prior to distributing the devices for use by their maternal and child health centres (mchcs). among some 300 iucds inspected belonging to lot number sm-3337-13, 4 devices were found to contain tiny hair-like or dust-like impurities inside their sterile pouches. so far, mchcs have not used iucds from the affected lot. the fhs reported the issue to the supplier as well as the medical device control office, which began investigation immediately. according to the supplier, about 950 devices from the affected lot were distributed to public and private hospitals and some private clinics. the dh has not received any relevant report of adverse incidents in hong kong. as a precautionary measure, the supplier is instructed to conduct a batch recall of the product with lot number sm-3337-13 from the market. the supplier has set up a hotline (3971 2913) for enquiries. healthcare professionals should stop using the affected products immediately. dh has brought the matter to relevant stakeholders' attention and will follow up on the investigation. ends.

Device

Multiload Radiopaque Cu375 intrauterine contraceptive devices
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of Multiload Radiopaque Cu375 intrauterine contraceptive devices (with photos)
  • Manufacturer
    Merck Sharp & Dohme (Asia) Limited

Manufacturer

Merck Sharp & Dohme (Asia) Limited