Events

Coopers Walking Frames 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Sunrise Medical Limited 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 연번
    SN2008(04)
  • 날짜
    2008-04-02
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/coopers-walking-frames&id=768df825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    A number of incidents have been reported to the irish medicines board (imb) relating to the use of these frames. this purpose of this notice is to: make users / prescribers aware of a quality improvement / design change implemented by the manufacturer in july 2006. ensure that the instructions for safe and effective device use are communicated.
  • 조치
    Ensure users / prescribers are aware of issues Familiarisation with the instructions for safe and effective device use, in particular the general safety and warning statements in the manufacturers’ instructions for use. Ensure that device is in proper working order before being put into service as these frames can be damaged during shipment or storage. Highlight to users the need for regular inspection of the device for damage or signs of wear in accordance with manufacturers guidelines and where necessary to take appropriate remedial action (in the form of replacement / repair).

Device

Coopers Walking Frames
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Coopers Walking Frames
  • Manufacturer
    Sunrise Medical Limited

Manufacturer

Sunrise Medical Limited