Events

Prostheses from EUROSILICONE laboratories 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 EUROSILICONE 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
    2001-11-05
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-protheses-des-laboratoires-eurosilicone
  • 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
    Several EUROSILICONE laboratory prostheses have been subjected to multiple sterilizations. Since this is a practice that has not been validated before being placed on the market and whose impact on products is unknown, Afssaps, in agreement with the EUROSILICONE laboratories, has decided to withdraw all these prostheses. The number of recipients being reduced, they were warned directly by the laboratory. All prostheses whose serial number begins with the letters A, B, C or D are affected and must be removed. As well as prostheses having the serial number E094I001, G175L018, E278I012, E286I010, E300I009 and E302I019. The elements at our disposal are not likely to jeopardize the safety of the patients to whom these prostheses were implanted. Nevertheless, an evaluation is in progress. No case of materiovigilance has been reported so far. Any time, it will be advisable to report to the material vigilance unit of the Afssaps (tel: 01 55 87 40 24 and fax: 01 55 87 37 02), any abnormality possibly found in these patients.

Device

Prostheses from EUROSILICONE laboratories
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    EUROSILICONE

Manufacturer

EUROSILICONE
  • Source
    LAANSM