Events

miraDry System (used for the treatment of primary axillary hyperhidrosis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Consulting Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-01234-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01234-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Device consulting has been advised that clinics may use substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly containing and cooling the skin and cause minor burns and blisters. whilst there have not been any adverse events reported in australia, device consulting is updating the user manual for the miradry system to include the statement: “do not use lubricants other than the recommended lubricants (k-y jelly or k-y liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
  • 조치
    Device Consulting is providing users with an updated user manual, including additional warnings regarding the use of non-validated solutions. This action has been closed-out on 26/08/2016.

Device

miraDry System (used for the treatment of primary axillary hyperhidrosis)
  • 모델명 / 제조번호(시리얼번호)
    miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967
  • Manufacturer
    Device Consulting Pty Ltd

Manufacturer

Device Consulting Pty Ltd