Events

S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm 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 Cordis® 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
    2017-02-16
  • 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
    Based on complaints and follow-up investigations, cordis found that the sizes of the 5x200 mm and 6x200 mm cordis® smart® flex cord system (a total of four part numbers) are associated with an increase in incidents involving installation problems, compared to others sizes.   the most commonly mentioned mounting problem is the inability to install the mount, which leads to an extended intervention time due to the preparation of the replacement accessory. partial placement of the abutment may also lead to ischemia or internal bleeding, which would require additional intervention.   since the launch of this product in 2013, there have been a total of three reported cases of patient injuries worldwide related to complaints of placement problems (one case of insertion bleeding and two cases of thrombus formation), which are not likely due to the use of the device. however, we cannot exclude any causal link at this time.

Device

S.M.A.R.T.® Flex sizes 5x200 mm and 6x200 mm
  • 모델명 / 제조번호(시리얼번호)
    lot range from 34469 to 39974
  • Manufacturer
    Cordis®

Manufacturer

Cordis®