Events

PROXIMATE PPH hemorrhoidal circular stapler batch 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
  • 날짜
    2008-02-07
  • 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-lots-d-agrafeuse-circulaire-hemorroidaire-proximate-pph-societe-ethicon
  • 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 06/02/08, the company ETHICON withdrew the lots C4FF4Y; C4FW34; C4G23W; C4FW0M; C4G001; D4G986; C4FW0N; C4G06R; D4GD5R of the PPH03 reference of the medical device called PROXIMATE® PPH Hemorrhoidal Circular Stapler. These batches were put on the market after a first recall in April 2007. This first recall was made following a risk of migration of the glue used to glue the outer shell in the guide system staples , may push the surgeon to prematurely interrupt his action, which would result in the incomplete formation of the staple line. The company ETHICON has directly notified the recipients of the incriminated lots with the message attached (06/02/2008) (33 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

PROXIMATE PPH hemorrhoidal circular stapler batch
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon