Events

Morcellex Tissue Morcators (Surgery) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ethicon 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
  • 사례 ID
    201410618
  • 날짜
    2014-08-18
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/morcellateurs-de-tissus-morcellex-chirurgie-ethicon-rappel-de-produit
  • 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
    The ANSM has been informed of the implementation of an action of a recall made by the company ETHICON. The users and health professionals concerned received the attached mail (18/08/2014) (65 KB). As a reminder, the ANSM published recommendations on laparoscopic morcellation for the surgical removal of uterine fibroids, following Ethicon's dispatch of an initial information indicating the suspension of marketing of their morcellation products in the month of March. May 2014. Morcellement by laparoscopy for surgical removal of uterine fibroids: ANSM recommendations - Informatio Point. (21/05/2014) Ethicon security note of 14/05/2014 (20/05/2014) (56 KB) This security action is registered with the ANSM under the number 201410618 .. You will have the possibility of consulting its progress on the Directory of the reports of materiovigilance by entering this n ° of registration.

Device

Morcellex Tissue Morcators (Surgery)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon