Events

POLIDENT PRO Complete Care;SUPER POLIGRIP;COREGA Maximum Adhesion;COREGA Maximum Performance;COREGA Freshness;COREGA Maximum Freshness Adherence 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 GSK Consumer Health 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
    2010-02-18
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retraits-de-lots-cremes-adhesives-pour-appareils-dentaires-polident-pro-soin-complet-super-poligrip-corega-adherence-maximum-corega-performance-maximum-corega-fraicheur-corega-adherence-maximum-fraicheur-gsk-sante-grand-public
  • 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
    As a precautionary measure, in agreement with Afssaps, GSK Consumer Health is recalling all batches of adhesive creams for dental appliances containing zinc: POLIDENT PRO Complete Care, SUPER POLIGRIP, COREGA Maximum Adhesion, COREGA Maximum Performance , COREGA Freshness, COREGA Maximum Freshness Adherence, following the identification of a potential health risk associated with excessive long-term use of these creams. Indeed, use in large quantities or several times a day for several years could lead to a high level of zinc in the body. For more information: www.maprothesedentaire.fr or at the toll free number 0800.975.57. Read auss. Marketing cessation of adhesive creams with zinc for dental appliances. (18/02/2010)

Device

POLIDENT PRO Complete Care;SUPER POLIGRIP;COREGA Maximum Adhesion;COREGA Maximum Performance;CORE...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    GSK Consumer Health

Manufacturer

GSK Consumer Health