Events

Safety Alert for HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BioScience GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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mix-up with hyacorp h 1000 and hyacorp h-s 500, hyacorp l, which is intended and approved for facial areas will be withdrawn as well.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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioScience HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500
  • Manufacturer
    BioScience GmbH

Manufacturer

BioScience GmbH
  • Source
    DH