TheraSphere Yttrium 90 Glass Microspheres 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Biocompatibles UK 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
    2015-09-23
  • 사례 출판 날짜
    2015-09-23
  • 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
    Medical device safety alert: biocompatibles uk therasphere yttrium 90 glass microspheres medical device manufacturer, biocompatibles uk (btg), has issued a medical device safety alert concerning its therasphere yttrium 90 (y-90) glass microspheres. the affected products are identified as follows:- lot number: 1599211; manufacturing date: 03-sep-2015; calibration date: 06-sep-2015; expiry date: 18-sep-2015 the manufacturer has recently become aware, via a customer complaint, of the mislabeling of one dose vial of therasphere y-90 glass microspheres lot 1599211 that was distributed in hong kong. the therasphere vial was labeled 10 gbq and the actual dose was 5 gbq (total radioactivity was incorrect). mislabelling of the therasphere y-90 glass microspheres may result in under- or over-dosing of the patient resulting in the patient not receiving their prescribed dose. under-dosing could result in lack of efficacy, and over-dosing could result in non-target tissue radiation. the manufacturer advises users to verify the accuracy of the dose measurement prior to administration. this recommendation is consistent with the therasphere training and reference material that the manufacturer provides to each user. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Biocompatibles UK TheraSphere Yttrium 90 Glass Microspheres
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DH