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 Bausch & Lomb Inc 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 051 12 12 000
  • 사례 시작날짜
    2012-12-10
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2714
  • 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
    Some 27g disposable cannulas manufactured by rhein medical, inc. provided with the amvisc or amvisc plus ovd are not properly engaging to the luer-lock on the amvisc and amvisc plus sterile glass syringes. the 27g disposable cannulas may leak viscoelastic material or detach from the syringe during injection. immediate consequences of cannula detachment during intraocular use could include damage to intraocular tissue.

Device

OVD, 27G disposable cannula Amvisc and Amvisc Plus devices
  • 모델명 / 제조번호(시리얼번호)
    Model numbers 59051,59081,60081 Model numbers 59051L, 59081L, 60051L, 60081L The OVD containing recalled cannula was manufactured between February 2010 to August 2012 with expiry dates ranging from December 2001 to June 2015
  • 의료기기 분류등급
    Ophthalmic Devices
  • 제품 설명
    OVD, Amvisc and Amvisc Plus devices
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • 제조사 모회사 (2017)
    Bausch Health Cos., Inc.
  • 제조사 대표
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA