Events

Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 manufacturer #17429 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/2015/034
  • 날짜
    2015-09-25
  • 사례 출판 날짜
    2015-09-25
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/implantable-medical-devices-manufactured-by-silimed-temporary-suspension-of-the-ce-certificate
  • 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
    The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices.MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
  • 원인
    Suspension due to particles found on some devices (mda/2015/034).
  • 조치
    Do not implant/use affected devices Quarantine devices Await further advice from the distributor(s) and/or MHRA If patients enquire they can be reassured that this situation is being investigated as a matter of priority with our European counterparts to decide on further action. However, if they would like to be kept up-to-date they can register for email updates and they will be kept informed.

Device

Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The following devices distributed in the UK by Eurosurgical are affected:silicone implants for plastic surgery: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery silicone invasive devices: sizers for silicone implants silicone implants for general surgery: blocks and sheetsThe following devices distributed in the UK by Genesis Medical are affected:implants for urology: testicular implants, penile implants, vaginal stents and periuretheral constrictors
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429