Events

Orthopedic devices for the treatment of fractures 의 안전성 경고

Ministry of Health에 따르면, 해당 안전성 경고 는 Lithuania 에서 Vigor Ortho, India 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
    1
  • 날짜
    2018-04-06
  • 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
    The orthopedic screws in the bundle are packed in plastic bags with a label affixed to them. no additional information on these propellers or their use has been added to the packaging. the label shows the manufacturer of the medical device: vigor ortho (india) but does not specify the manufacturer's authorized representative in the european community (does not meet the requirement of annex 1, paragraph 14.3.1 of the regulation); the label states that the medical device is placed on the market non-sterile but does not provide information on how this medical device should be sterilized before its intended use (implantation) (does not meet the requirement of annex 1, paragraph 14.3.10 of the regulation); eudamed, the european database for medical devices, has no information on the manufacturer vigor ortho (india), and there is no information that this manufacturer will be issued with a certificate of compliance with the requirements of the council directive 93/42 / eec on medical devices. commodities are ce marked with the number of the notified body 2107. the list of notified bodies of existing medical devices published by the european commission in the notified bodies of the european commission does not include the notified body number 2107 (does not meet the requirements of article 40 of the regulation).
  • 조치
    Do not allow to enter the Lithuanian market

Device

Orthopedic devices for the treatment of fractures

Manufacturer

Vigor Ortho, India
  • 제조사 대표
    JSC Gameda
  • Source
    MH