Events

Alerta De Seguridad O Notificaciones De Seguridad para Novabel® dermal filler

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Merz Pharmaceuticals GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2010/064
  • Fecha
    2010-08-11
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-novabel-dermal-filler-practitioners-should-stop-use-and-return-all-unused-products
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    (merz pharmaceuticals gmbh) manufacturer has received reports of adverse reactions to the filler. (mda/2010/064).
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    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
  • Dirección del fabricante
    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
  • Empresa matriz del fabricante (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    MHRA