Wheeled and non-wheeled walking frames (all models) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Patterson Medical 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
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2013/060
  • 날짜
    2013-08-01
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    Potential for detachment of the wheels and/or inadequately tightened screws, which may cause the user to fall.Frames of specific batches produced from January 2013 to March 2013 may not have been manufactured to specification.The manufacturer issued a Field Safety Notice (158Kb) in May 2013, but has not had confirmation from a significant number of customers that they have received and acted upon this information.
  • 원인
    (patterson medical) may cause the user to fall. (mda/2013/060).
  • 조치
    Ensure that those responsible for provision and maintenance of these devices:identify affected devices perform the checks and actions detailed in the manufacturer’s Field Safety Notice (158Kb) complete the reply letter and return it to Patterson Medical.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Wheeled and non-wheeled walking frames (all models).Manufactured by Patterson Medical.Batch codes from DMW12013 to DMW82013 inclusive.Note - paediatric walking frames manufactured by Patterson Medical are not affected.
  • Manufacturer

Manufacturer

  • 제조사 주소
    ManufacturerPatterson Medical Customer Services North Road Bridgend Industrial Estate Bridgend Wales, CF31 3TP Tel:    0844 412 4330 Fax:   0844 873 0100Email:    retail.sales@pattersonmedical.com
  • 제조사 모회사 (2017)
  • Source
    MHRA