Events

Novabel® dermal filler 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Merz Pharmaceuticals GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2010/064
  • 날짜
    2010-08-11
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-novabel-dermal-filler-practitioners-should-stop-use-and-return-all-unused-products
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    (merz pharmaceuticals gmbh) manufacturer has received reports of adverse reactions to the filler. (mda/2010/064).
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    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
  • 제조사 주소
    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
  • 제조사 모회사 (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    MHRA