Events

Safety Alert for Novabel Dermal Filler

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Merz Pharmaceuticals 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
    2010-07-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100802.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
    Press release
  • Reason
    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

Manufacturer

Merz Pharmaceuticals GmbH