Events

Alerte De Sécurité sur HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BioScience 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
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • 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_20131016.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: bioscience hyacorp l, hyacorp h 1000 and hyacorp h-s 500 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning injectable dermal fillers hyacorp l (ref bs067), hyacorp h 1000 (ref bs068) and hyacorp h-s 500 (ref bs078) manufactured by bioscience gmbh. bioscience has decided to recall hyacorp h 1000 and hyacorp h-s 500 from european market after identifying a trend related to off-label use of the products. hyacorp h 1000 and hyacorp h-s 500 have been used for volume enhancement in the face which is against the intended use defined by the manufacturer. the manufacturer explains that off-label use of the products has led to serious complications such as long lasting swelling, redness, formulation of thyroid nodules and inflammation. in order to prevent mix-up with hyacorp h 1000 and hyacorp h-s 500, hyacorp l, which is intended and approved for facial areas will be withdrawn as well. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.

Device

HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioScience HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500
  • Manufacturer
    BioScience GmbH

Manufacturer

BioScience GmbH
  • Source
    DH