Events

Correct Plus Bite Superfast 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Kimberly-Clark 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
    2012-07-11
  • 사례 출판 날짜
    2012-07-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120711a.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: kimberly-clark ultra fabric reinforced surgical gown x-large, sterile medical device manufacturer, pentron clinical issued a medical device safety alert concerning correct plus bite superfast. the affected part numbers are q34ia and q34ic. according to the manufacturer, the current directions for use (dfu) for correct plus bite superfast lists a working time that is not indicative of the actual performance of the product. the current dfu lists the total working time as 25 seconds, while the material actually provides a minimum working time of 15 seconds as outlined in the chart below: the manufacturer explained that there are no safety or efficacy concerns associated with correct plus bite superfast. for details, please refer to the attachment. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 july 2012.

Device

Correct Plus Bite Superfast
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Pentron Clinical Correct Plus Bite Superfast
  • Manufacturer
    Kimberly-Clark

Manufacturer

Kimberly-Clark