ProLift S 222 Standsupport Slings 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Novacare 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
    2013-12-24
  • 사례 출판 날짜
    2013-12-24
  • 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: novacare prolift s 222 standsupport slings the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning prolift s 222 standsupport slings, manufactured by novacare. details of affected products are as follows: model no.: sizes s, m and l lot no.: all production date: september 2012 according to the manufacturer, the internal quality control system has found a problem with slings produced for the prolift s222 sit-to-stand hoist as from september 2012. some slings have not been correctly sewn. the strap which holds the buckle for the back support could tear under load. this could lead to the patient falling backwards out of the hoist and therefore a high security risk exists. the manufacturer advises customers to check the production date on the sewn on label. all slings will be inspected by the manufacturer’s quality control department and either revised or replaced and then returned to customers. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con355483 if you are in possession of the product, please contact your supplier for necessary actions. posted on 24 december 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Novacare ProLift S 222 Standsupport Slings
  • Manufacturer

Manufacturer

  • Source
    DH