Events

TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 CooperSurgical under different brand names 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/2015/025
  • 날짜
    2015-07-06
  • 사례 출판 날짜
    2015-07-06
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/transwarmer-infant-transport-mattress-novaplus-transwarmer-infant-heat-therapy-mattress-with-warmgel-infant-heel-warmer-risk-of-serious-burn
  • 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
  • 원인
    (coopersurgical under different brand names) risk of serious burn if device is used past its expiry date (mda/2015/025).
  • 조치
    Identify and quarantine all product that does not have a lot or expiry date on the packaging (check the transport mattress field safety notice (FSN) and heel warmer FSN. Discard or return affected product to your supplier. Return the relevant acknowledgement and receipt form to the manufacturer.

Device

TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with Wa...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    MattressesPackage label Part Product description CooperSurgical 20421 TransWarmer® infant transport mattress NovaPlus V6390 NovaPlus TransWarmer® infant heat therapy mattress with WarmGel®Heel warmersPackage label Part Product description CooperSurgical 20418 WarmGel infant heel warmer CooperSurgical 24401 Liquid infant heel warmer Fisher Brand 24647 FISHERBRAND gel infant heel warmer Fisher Brand 24646 FISHERBRAND liquid infant - heel warmer MediChoice 24649 MEDICHOICE warmgel infant heel warmer MediChoice 24648 MEDICHOICE liquid infant - heel warmer NovaPlus V6391 WARMGEL infant heel warmer - NOVAPLUS NovaPlus V6393 Liquid infant heel warmer - NOVAPLUS
  • Manufacturer
    CooperSurgical under different brand names

Manufacturer

CooperSurgical under different brand names
  • 제조사 주소
    CooperSurgical Attn: Product Surveillance 75 Corporate Dr Trumbull CT 06611, USA USA phone: +1 203-601-5200 ext. 3414 USA fax: +1 203-601-9870Email: productsurveillance@coopersurgical.comEuropean Authorised Representative – Emergo Europe Telephone: +31 70 346 7299Email: vigilance@emergogroup.com
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    MHRA