Events

Mona Lisa CuT 380A QL 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 HRA Pharma 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 날짜
    2009-02-20
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lot-de-dispositif-medical-intra-uterin-mona-lisa-cut-380a-ql-hra-pharma
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    On 19/02/09, the company HRA Pharma withdrew from the market lot 2007E04A (expiry 05/2011) of the intrauterine medical device Mona Lisa CuT 380A QL following claims describing, due to a manufacturing defect, the impossible passage of the intra-uterine device through the insertion tube, thus preventing its insertion in the patient. The users concerned were informed by the laboratory, directly from the attached messages (20/02/2009) (96 ko ) or by general distribution to wholesalers / pharmacies and pharmacies of health establishments (20/02/2009) (97 KB). This information is addressed to the directors and correspondents of materiovigilance of the health establishments for diffusion if necessary to the services concerned, to the gynecologists of town, to the centers of maternal and infant protection and to the general councils concerned, to the wholesale distributors and pharmacists of town.

Device

Mona Lisa CuT 380A QL
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    HRA Pharma

Manufacturer

HRA Pharma