Events

Alerte De Sécurité sur Novabel 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 Merz Pharmaceuticals GmbH.

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
    2010-07-31
  • 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_20100802.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
    Caution on novabel dermal filler the department of health (dh) has drawn public attention to reports of adverse reactions as a result of using novabel dermal filler, an implantable material for reconstruction and body contouring. dh, through its routine surveillance, found that the uk's medicines and healthcare products regulatory agency (mhra) announced that a manufacturer in germany had issued a notice to advise clinicians not to use novabel because of the dissatisfactory aesthetic outcome. the agency is assessing the adverse reactions. the affected products included all batches of novabel, dermal filler (1x1ml, art.-nr. 40800) and novabel, dermal filler (2x1ml, art.-nr. 49021). according to the manufacturer, an overall number of 70 cases of adverse reactions were reported from about 24,000 syringes sold. the reactions included redness, bruising, pain and swelling. some patients had visible and palpable nodules and indurations. many of these have resolved since being reported. while dh is obtaining more information from mhra, as precautionary measures, dh has informed healthcare professionals of hospital authority, private hospitals, and relevant medical professional associations about the alert. the spokesman said members of the public who have these reactions after using the concerned product should consult their healthcare providers. dh will monitor future developments. ends/saturday, july 31, 2010.

Device

Novabel Dermal Filler
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Caution on Novabel Dermal Filler
  • Manufacturer
    Merz Pharmaceuticals GmbH

Manufacturer

Merz Pharmaceuticals GmbH