Events

MAD Nasal™ Intranasal Mucosal Atomization Device 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 Teleflex 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
    Field Safety Notice
  • 날짜
    2016-10-28
  • 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
    Teleflex medical has decided to recall the above products because it may not be possible for the product to deliver a fully dispersed nebula drug. teleflex medical has received complaints that the affected batch of products produces a flat stream instead of a diffused mist of medicine. if the device does not deliver the mist of the sprayed drug, this may adversely affect the performance of the drug used on the device. this can lead to serious injury or death in certain emergencies when the device is used in a non-indicated mode, such as delivering drugs without a needle to save a life-threatening drug overdose, to save a life in the event of a severe hypoglycemia or treatment of seizures.

Device

MAD Nasal™ Intranasal Mucosal Atomization Device
  • 모델명 / 제조번호(시리얼번호)
    MAD100 160105 MAD130OS 160436 MAD300 160409 160137 160803 160422 160302 MAD140 160125 160432 160321 160218 160440 160402 160437 160500 160435 160610 160518 160506 160801 160602 160523 MAD140OS 160226 160611 160609 160438 160621 160620 160727 160631 160707 MAD300 160108 160701 160802 160117 160708 160813 160126 160718 MAD100OS 160322 160145 160728 160524 160146 160800 160630 160200 160804 MAD110 160217 160219 160814 160507 160225 160816 MAD110OS 160240 160231 160823 160312 160300 MAD300B 160410 MAD130 160107 160313 160138 160327 160517 160400
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical