Events

Confidence Spinal Cement System 를 위한 리콜 또는 안전성 경고

Central Drugs Standard Control Organization에 따르면, 해당 리콜 또는 안전성 경고 는 India 에서 Depuy Spine Inc 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
    Recall / Safety Alert
  • 사례 ID
    31-608-MD/2009-DC (Re. Registration 2011)
  • 날짜
    2014-01-15
  • 사례 국가
    India
  • 사례 출처
    CDSCO
  • 사례 출처 URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • 비고 / 경고
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • 데이터 추가 비고
  • 원인
    Voluntary recall has been initiated due to the reason that during injection of cement, (the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject the cement. this could result in surgical delay which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the another reason has been reported that , firm reported that the cement mixer used to prepare cement for surgery has been identified to not tum properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to addtiional anesthesia in another surgical procedure.
  • 조치
    Johnson & Johnson has ceased distribution of the product while evaluating appropriate corrective and preventive actions.

Device

Confidence Spinal Cement System
  • 모델명 / 제조번호(시리얼번호)
    283910000
  • Manufacturer
    Depuy Spine Inc

Manufacturer

Depuy Spine Inc