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 MATHYS 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 005 10 13 000
  • 사례 시작날짜
    2013-10-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4438
  • 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
    Mathys ltd bettlach (mathys) has been notified of an incident in where the optimys opening broach broke intraoperatively and the fragment was left in the bone. investigations have shown that the instrument was not used in compliance with the instructions, and detailed exploration revealed that this was causal to the incident. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favor breakage in case of non-compliant usage.

Device

Bone rasp , optimys Opening Broach bent
  • 모델명 / 제조번호(시리얼번호)
    Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
  • 제품 설명
    Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
  • Manufacturer
    MATHYS

Manufacturer

MATHYS