Events

BioMatrix NeoFlex 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Biosensors 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
    2013-08-16
  • 사례 출판 날짜
    2013-08-16
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816.html
  • 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: biosensors biomatrix neoflex it has come to our attention that medical device manufacturer, biosensors, has initiated a field safety corrective action concerning its biomatrix neoflex. in specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action. if not identified prior use, the hub cracking may potentially lead to treatment delays or complications. the manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013. the manufacturer advises users to identify, quarantine and return affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BioMatrix NeoFlex
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Biosensors BioMatrix NeoFlex
  • Manufacturer
    Biosensors

Manufacturer

Biosensors