Events

Mirena 의 안전성 경고

Health Ministry (Panama)에 따르면, 해당 안전성 경고 는 Panama 에서 Bayer Pharma AG 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
  • 날짜
    2017-05-16
  • 사례 출판 날짜
    2017-05-22
  • 사례 국가
    Panama
  • 사례 출처
    HMP
  • 사례 출처 URL
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2017&page=6
  • 비고 / 경고
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 Panama.
  • 데이터 추가 비고
  • 원인
    Following the notification of the mirena® product 20mcg / 24 hours (lntrauterine system) in which the findings found in lot tu01btw of the product cited in the reference had been communicated and consequently to the corrective and preventive actions carried out, it informs that the lot tu01btw which was blocked in the international warehouses of bayer j. cain, has been 100% inspected, no unit being found with the inserter assembled incorrectly. as seen in the following image, part of the primary packaging material of the product is transparent, so the position of the inserter is easily visualized without contamination of the product, due to the above we confirm that all units of the tu01btw lot were inspected to ensure that the inserter was in the correct position.

Device

Mirena
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Mirena® is an intrauterine device that contains levonorgestrel, a progestagen with antiestrogenic activity, that releases 20 µg of the hormone every 24 hours directly into the intrauterine cavity.
  • Manufacturer
    Bayer Pharma AG

Manufacturer

Bayer Pharma AG