Events

Various devices 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 VASCUTEK Ltd 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
  • 날짜
    2017-11-30
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    This notice is to inform you about important information concerning updates to the instructions for use (ifu) for the above products. vascutek ltd has taken the opportunity to conduct a full review of the ifu contents to ensure consistency across all product families and to ensure that the instructions for use provide state of the art instruction and content to users. as a result of these updates, further clarity will be provided to clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process. further details are provided overleaf,.

Device

Various devices
  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial Number All Gelsoft^", Gelsoft™ ERS, Gelsoft™ Plus, Gelsoft™ Plus ERS, Gelseal™, Gelseal™ ERT, Gelweave™, K-Thin, K-Thin ERS, and Gelseal™ Plus Vascular Prostheses All Fluoropassiv™, Fluoropassiv™ ER, Thin Wall Fluoropassiv and Thin Wall Fluoropassiv ER Vascular Prostheses All Cardiovascular Fabric Patches All SealPTFE™ and Taperflo™ Vascular Prostheses All Lots
  • Manufacturer
    VASCUTEK Ltd

Manufacturer

VASCUTEK Ltd