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 St. Jude Medical 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 038 10 18 001
  • 사례 시작날짜
    2018-11-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13437
  • 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
    As background, abbott believe that some of the listed leads may contain an electrode that does not conform to their material specification. in total, there have been four (4) reports from (2) centers describing that the most proximal stimulation tip electrode (electrode position 4) appeared lighter than the more distal electrodes when radiographed. there have been no reports of patient harm to date. further communication with additional details about this action, inclusive of management recommendations for any patients that may have been implanted with an affected lead, will be forthcoming as soon as possible.

Device

8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) System
  • 모델명 / 제조번호(시리얼번호)
    Model No.: 6172ANS, 6170ANS Multiple batch & serial numbers (See attached FSN) UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320
  • 제품 설명
    Implantable Pulse Generators
  • Manufacturer
    St. Jude Medical Inc.

Manufacturer

St. Jude Medical Inc.
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • 제조사 대표
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA