Events

Solus Flexible Wire Reinforced Laryngeal Mask Airway 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Intersurgical 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
  • 날짜
    2017-06-09
  • 사례 출판 날짜
    2017-06-09
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/solus-flexible-wire-reinforced-laryngeal-mask-airway-risk-of-hypoxia-due-to-partial-or-total-occlusion-of-the-airway-tube-after-inflating-the-cuff
  • 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
    Manufactured by intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
  • 조치
    Identify affected devices (see below) and stop using them. Quarantine and destroy all affected devices in stock. Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.

Device

Solus Flexible Wire Reinforced Laryngeal Mask Airway
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The following models and LOT numbers are affected:Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2 Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5 Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3 Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4 Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5LOT numbers: from 31310139 to 31703855 inclusive.REF numbers NHS Supply Chain Codes Scottish NDC Codes 8002001 FDD1640 n/a 8025001 FDD1641 n/a 8003001 FDD1642 NDC SKU 057290 8004001 FDD1643 NDC SKU 057306 8005001 FDD1644 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • 제조사 주소
    Intersurgical Ltd Telephone: 0118 9656 300 Fax: 0118 9656 356Email: info@intersurgical.co.uk
  • 제조사 모회사 (2017)
    Etablissement Cosmeplast
  • Source
    MHRA