Events

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC. 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
    142920
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-05-27
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. recurrence / reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.

Device

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: PHY3050R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY3035R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2535V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2030R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY0715R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1515Q (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1015V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2025V (Lot serial: >100 NUMBERS (ALL LOTS))
  • 제품 설명
    PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.