Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Etac 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 026 11 11 000
  • 사례 시작날짜
    2011-11-07
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1000
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Wheels may come off caused by assembling error of lock ring, causing a risk of injury. etac has in a ten year period had 41 registered incidents, approximately one (1) of six thousand (6000) delivered walker etac ono, involving the walker ono and wheels coming off. etac also have got information that additional incidents have occurred not reported to etac. when delivered from etac the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and can then not be fastened properly.

Device

Walking frame, wheeled
  • 모델명 / 제조번호(시리얼번호)
    Walker Ono 15041201-14 up to serial no 223000
  • 제품 설명
    Walker
  • Manufacturer
    Etac

Manufacturer

Etac