injectable dermal filler, Macrolane for breast augmentation 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Q-MED 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2012-04-23
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Mhra issues updates on the use of injectable dermal filler, macrolane for breast augmentation the medicines and healthcare products regulatory agency (mhra), united kingdom has issued updated information about macrolane, an injectable dermal filler manufactured by q-med. q-med has decided to discontinue macrolane for use in breast augmentation as the product may interfere with the reading of mammograms and could make diagnosis more difficult. people who have undergone breast augmentation with macrolane should inform the healthcare professional conducting their breast examination of the date of their last macrolane treatment prior to the assessment. according to the manufacturer and the mhra, there are no safety concerns with the product and the product can still be used in its other indications. according to the local supplier, the affected products have been distributed in hong kong. for details, please visit the mhra website: http://www.Mhra.Gov.Uk/newscentre/con149797 if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: [23 Apr 2012] MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation
  • Manufacturer

Manufacturer