Events

Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L (3D-23G-90mm), COG PDO Tread Blunt (3DB19G-100mm), 3D COG Thread Sharp (3D-22G70mm) 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
    6
  • 날짜
    2017-11-24
  • 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 medical devices are marked with two ce conformity marks with the number of the notified bodies 1282 and 0197. in accordance with the provisions of the regulation, the ce marking must be accompanied by the identification number of one of the notified bodies responsible for applying the procedures set out in the annexes to this regulation. in addition, the ce mark does not conform to the form set out in annex 12 to the regulation. such marking does not comply with the requirements of articles 38-40 of the regulation; instructions for use have not been added to medical devices as required by annex 1, paragraph 14.1 of the regulation; medical devices do not include the name and address of the manufacturer and the authorized representative within the european union and its address as required by annex 1, paragraph 14.3.1 of the regulation.
  • 조치
    Not allowed to enter the Lithuanian market

Device

Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L ...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Not specified

Manufacturer

Not specified
  • 제조사 대표
    UAB Urmo Group
  • Source
    MH