Events

Alerte De Sécurité sur Restylane SubQ Lidocaine 2ml dermal filler

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

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
    2013-02-21
  • 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_20130222.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 restylane subq lidocaine 2ml dermal filler the department of health (dh) today (february 21) drew public attention to the recall of a dermal filler, restylane subq lidocaine 2ml (batch numbers: 11907 and 11516), due to defects in the sealing of the package which might compromise the external sterility of syringes containing the product. the dh received notification from the product's local supplier, galderma hong kong limited, that the swedish manufacturer, q-med ab, had initiated a recall of the above product. "according to the manufacturer, the decision to recall the affected products from the market is due to defects in the sealing of the package. while the sterility of the content inside the syringe is unaffected, defects in the package mean that the external sterility of the syringe can no longer be guaranteed," a dh spokesperson explained. "further investigation into the local supplier's product distribution records shows that it has distributed the affected products, comprising about 170 pieces, to medical clinics and beauty centres from june 2012 to february 2013," the spokesperson added. so far, the dh has not received any adverse event reports related to the products. the dh will closely monitor the recall. in case members of the public have the products in their possession, they can contact galderma on its hotline (2238 0900) for public enquiries. the spokesperson also reminded the public that anyone who is in doubt or feeling unwell after having used the product should consult health-care professionals. the dh has informed public and private hospitals and relevant medical associations about the issue. ends.

Device

Restylane SubQ Lidocaine 2ml dermal filler
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of Restylane SubQ Lidocaine 2ml dermal filler
  • Manufacturer
    Q-Med AB

Manufacturer

Q-Med AB