Events

Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBoneScrew) 의 안전성 경고

Ministry of Health에 따르면, 해당 안전성 경고 는 Lithuania 에서 Not specified 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 연번
    5
  • 날짜
    2017-12-01
  • 사례 국가
    Lithuania
  • 사례 출처
    MH
  • 사례 출처 URL
    http://www.vaspvt.gov.lt/node/115
  • 비고 / 경고
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • 데이터 추가 비고
  • 원인
    Manufacturer and its authorized representative in the european economic area not indicated on the label of the medical device and on the outer packaging and the address is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); packages of medical devices are not marked with the ce conformity marking and the number of the notified body (not in accordance with the requirements of points 38 and 40 of the regulation); the medical device label is marked with the symbol "see instructions for use", but the instructions for use are not included (does not meet the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not contain the information necessary to identify the medical device and the contents of the packaging (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); the expiry date of the medical device labels is "2017-0919". in view of this, the period of validity (fitness for use) of medical devices has expired and can no longer be used.
  • 조치
    Do not allow to enter the Lithuanian market

Device

Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBone...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Not specified

Manufacturer

Not specified
  • 제조사 대표
    UAB Urmo Group
  • Source
    MH