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 Stryker 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 094 10 11 000
  • 사례 시작날짜
    2011-10-31
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=973
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    There is potential for the blade to break from the arbor while the surgeon is cutting mandibular bone. the broken piece may: 1. fall into the surgical site. this may result in possible: a. delay in surgery time whilst the surgeon removes the part and obtains a replacement device the probability of occurrence is low. 2. be swallowed or aspirated into the lungs. this may result in possible: a. delay in surgery time b. tissue damage c. need for further surgery to remove the part. d. infection should the part not be removed the probability of occurrence is negligible. 3. become lodged in the mandibular bone. this may result in possible: a. delay in surgery time b. need for further surgery to remove the part c. need for x-rays and mri scans to locate the part i. mri rays may cause temporary temperature changes of the remaining implanted part. d. infection should the part not be removed the probability of occurrence is remote.

Device

Inferior Border Osteotomy (IBO) blades
  • 모델명 / 제조번호(시리얼번호)
    Catalogue No: 5100-037-901; 5100-037-902; 5100-037-903; 5100-037-901S2; 5100-037-902S2 Lot No: All lots manufactured from the 31st July 31 2006 to 15th June 2011 All lots with expiry dates from 1st July 2011 to 1st July 2016
  • 제품 설명
    IBO, blades
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • 제조사 모회사 (2017)
    Stryker
  • 제조사 대표
    Al-Faisaliah Medical System
  • Source
    SFDA