Events

Alerta De Seguridad para HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BioScience GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-10-16
  • Fecha de publicación del evento
    2013-10-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioScience HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500
  • Manufacturer
    BioScience GmbH

Manufacturer

BioScience GmbH
  • Source
    DH