Events

Lynx™ System, Suprapubic Sling, Obtryx™ System 에 대한 현장 안전성 서한

Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems에 따르면, 해당 현장 안전성 서한 는 Czechia 에서 Boston Scientific Corporation 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
    Field Safety Notice
  • 사례 ID
    628
  • 날짜
    2016-06-29
  • 사례 국가
    Czechia
  • 사례 출처
    MHSIDCCCDMIS
  • 사례 출처 URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • 비고 / 경고
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • 데이터 추가 비고

Device

Lynx™ System, Suprapubic Sling, Obtryx™ System
  • 모델명 / 제조번호(시리얼번호)
    Model Number: viz seznam soucasti FSN Product Description UPN AdvantageTM System M0068502000 AdvantageTM System, 5-Pack M006850200051 Advantage FitTM System M0068502110 Advantage FitTM System, 5-Pack M0068502111 LynxTM System M0068503000 LynxTM System, 5-Pack M0068503001 ObtryxTM System, Curved M0068504000 ObtryxTM System, Curved 5-Pack M0068504001 ObtryxTM System, Halo M0068505000 ObtryxTM System, Halo 5-Pack M0068505001 ObtryxTM II System with PrecisionBlueTM Design, Curved M0068504110 ObtryxTM II System with PrecisionBlueTM Design, Curved 5-Pack M0068504111 ObtryxTM II System with PrecisionBlueTM Design, Halo M0068505110 ObtryxTM II System with PrecisionBlueTM Design, Halo 5-Pack M0068505111 Solyx™ SIS System M0068507000 Solyx™ SIS System, 5-Pack M0068507001 UpholdTM LITE Vaginal Support System with CapioTM SLIM M0068318170 PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM M0068318150 UpsylonTM Y Mesh Kit with ColpassistTM Vaginal Positioning Device M0068318220 Product Description UPN XenformTM Soft Tissue Repair Matrix, 2cm x 7cm M0068302410 XenformTM Soft Tissue Repair Matrix, 4cm x 7cm M0068302430 XenformTM Soft Tissue Repair Matrix, 6cm x 10cm M0068302450 XenformTM Soft Tissue Repair Matrix, 8cm x 12cm M0068302470
  • 제품 설명
    Inactive implantable medical devices
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS