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 Ethicon Endo Surgery 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 002 06 16 000
  • 사례 시작날짜
    2016-06-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9451
  • 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
    Ethicon has initiated a voluntary product recall of ethicon physiomesh™ flexible composite mesh (for laparoscopic use) (“ethicon physiomesh™ composite mesh”). ethicon is recalling the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh™ composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. consequently, ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ethicon physiomesh™ composite mesh from the global market.

Device

ETHICON PHYSIOMESH Flexible Composite Mesh
  • 모델명 / 제조번호(시리얼번호)
    (All Product Codes)
  • 제품 설명
    Hernia Repair
  • Manufacturer
    Ethicon Endo Surgery Inc

Manufacturer

Ethicon Endo Surgery Inc
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • 제조사 대표
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA