Events

SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard Australia 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-2016-RN-01314-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01314-1
  • 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
    It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect instruction for use (ifu) containing a table in the description section that misidentifies the wireform and material (titanium and stainless steel). all other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a senomark ultracor mri 14 gauge tissue marker of the wrong material in a patient with known hypersensitivity to titanium.
  • 조치
    Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. This action has been closed-out on 17/05/2017.

Device

SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast bio...
  • 모델명 / 제조번호(시리얼번호)
    SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)Product code: SMUCMRI14GTLot number: VT15M0543ARTG number: 160027
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd