Events

Prostaflow Prostate Probes 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Coloplast 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
    2010-12-06
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/sondes-prostatiques-prostaflow-coloplast-retrait-de-lots
  • 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 30/11/2010, coloplast removed the lots from the market. lots No. 10060259 and No. 10051477 (ref AB7822, lot No. 10061659) (ref AB7824) of the medical device called Prostaflow Prostate Probes, manufactured by Coloplast Following several reports, it has been shown that the valve some of the probes of the concerned batches present a defect which causes the deflation of the balloon The company Coloplast directly warned the recipients of the incriminated batches by means of the enclosed message validated by Afssaps (06/12/2010) ( This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

Prostaflow Prostate Probes
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Coloplast

Manufacturer

Coloplast