Events

Safety Alert Or Field Safety Notices for Novabel® dermal filler

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Merz Pharmaceuticals GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2010/064
  • Date
    2010-08-11
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-novabel-dermal-filler-practitioners-should-stop-use-and-return-all-unused-products
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    Use of Novabel® dermal filler may cause adverse reactions.Merz Pharmaceuticals GmbH issued a Field Safety Notice (dated 23 July 2010), advising practitioners to stop using Novabel®.The manufacturer has received reports of adverse reactions to the filler including redness, bruising, pain, swelling and histologically confirmed granuloma. They have also received reports of nodules and indurations in the infra-orbital area.
  • Reason
    (merz pharmaceuticals gmbh) manufacturer has received reports of adverse reactions to the filler. (mda/2010/064).
  • Action
    Do not use Novabel® dermal filler. Return all unused product to Merz Pharma UK Ltd. Monitor patients who have received Novabel® and in particular those who exhibit symptoms linked to the use of Novabel®. If you administer Novabel®: cease use of the product return unused syringes to Merz Pharma UK Ltd. following application, patients should have been advised to return and seek treatment in case of progressive adverse reactions including redness, bruising, pain, swelling, nodules, indurations and granuloma follow up patients who exhibit residual adverse symptoms (described above) three months after application where symptoms persist, consider referring patients to a plastic surgeon for further treatment. If you are a plastic surgeon: if a patient presents with symptoms linked to Novabel® use, consider the need to treat with minocycline or injectable steroids.

Device

Novabel® dermal filler
  • Model / Serial
  • Product Description
    Novabel® dermal filler.Manufactured by Merz Pharmaceuticals GmbH.1x1 ml, Art.-Nr. 40800 and 2x1ml, Art.-Nr. 49021.All batches.Novabel® is a colourless dermal filler composed of cross-linked alginate. It is supplied in a prefilled, 1 ml, single-use syringe with two sterile 30G ½ needles.
  • Manufacturer
    Merz Pharmaceuticals GmbH

Manufacturer

Merz Pharmaceuticals GmbH
  • Manufacturer Address
    Medical Information Department Merz Pharma UK Ltd 260 Centennial Park Elstree Hill South Elstree Herts WD6 3SR Tel: 020 8236 0000 Fax: 020 8236 3501Email: medical.information@merz.com
  • Manufacturer Parent Company (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    MHRA