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 Medtronic 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 077 07 14 000
  • 사례 시작날짜
    2014-07-17
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6153
  • 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
    This voluntary removal is being conducted due to a single component of the catheter, the retainer ring. medtronic has not received any complaints due to this issue and is investigating the possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconnecting the catheter from the pump during a revision procedure.

Device

Ascenda Intrathecal Catheters / Revision Kit
  • 모델명 / 제조번호(시리얼번호)
    Specific Serial numbers of Models 8780, 8781, and 8784 Affected Product Serial Number List : 0208400011 0208422585 0208422700 0208423311 0208448076 0208452115 0208453913 0208477579 0208404256 0208422586 0208422701 0208430409 0208448077 0208452432 0208453914 0208477580 0208408588 0208422587 0208422702 0208430410 0208448078 0208452436 0208453916 0208477585 0208408589 0208422588 0208422703 0208430411 0208448079 0208453197 0208453917 0208477586 0208408590 0208422589 0208422704 0208430412 0208448343 0208453198 0208453918 0208479311 0208408591 0208422590 0208422705 0208430413 0208448344 0208453199 0208453919 0208479318 0208408592 0208422591 0208422706 0208438523 0208448347 0208453580 0208453920 0208482807 0208408593 0208422592 0208422707 0208438524 0208448360 0208453581 0208456065 0208482808 0208408594 0208422593 0208422708 0208438530 0208448361 0208453600 0208456066 0208483028 0208408595 0208422594 0208422713 0208438532 0208448370 0208453601 0208457223 0208489023 0208408598 0208422595 0208422714 0208438594 0208448371 0208453602 0208457240 0208490257 0208409021 0208422596 0208422715 0208439140 0208448372 0208453603 0208457241 0208493199 0208409022 0208422597 0208422718 0208439141 0208448373 0208453605 0208457242 0208493200 0208409023 0208422598 0208422719 0208439142 0208448374 0208453606 0208460808 0208493233 0208409024 0208422599 0208422780 0208439143 0208448375 0208453607 0208461923 0208493234 0208409031 0208422600 0208422781 0208439144 0208448376 0208453608 0208461924 0208493415 0208409033 0208422602 0208422782 0208439146 0208448379 0208453612 0208461948 0208493484 0208409034 0208422603 0208422783 0208439147 0208448422 0208453615 0208463831 0208501349 0208409035 0208422604 0208422784 0208439148 0208448423 0208453620 0208466272 0208506987 0208409036 0208422605 0208422793 0208439149 0208448424 0208453621 0208466273 0208506988 0208409039 0208422620 0208422794 0208439150 0208448425 0208453622 0208466982 0208409041 0208422621 0208422795 0208439151 0208448426 0208453900 0208469564 0208409042 0208422622 0208422799 0208439157 0208448427 0208453901 0208474584 0208421471 0208422625 0208422800 0208439164 0208448435 0208453904 0208474585 0208421802 0208422626 0208422801 0208439165 0208448436 0208453905 0208474586 0208422192 0208422627 0208422802 0208439174 0208448439 0208453906 0208474822 0208422553 0208422628 0208422803 0208439178 0208448460 0208453907 0208474827 0208422564 0208422629 0208422804 0208439179 0208448461 0208453908 0208477573 0208422580 0208422630 0208422805 0208439200 0208448462 0208453909 0208477574 0208422582 0208422632 0208422807 0208448073 0208448463 0208453910 0208477576 0208422583 0208422638 0208422808 0208448074 0208448464 0208453911 0208477577 0208422584 0208422639 0208422809 0208448075 0208452114 0208453912 0208477578
  • 제품 설명
    Drug infusion pump
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • 제조사 대표
    Gulf Medical Co., (012) 6512828
  • Source
    SFDA