Events

Alerte Ou Avis De Sécurité sur Novabel® dermal filler

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Merz Pharmaceuticals GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2010/064
  • Date
    2010-08-11
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-novabel-dermal-filler-practitioners-should-stop-use-and-return-all-unused-products
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    (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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Adresse du fabricant
    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
  • Société-mère du fabricant (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    MHRA