Events

Ethicon Physiomesh Flexible Composite Mesh 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 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
    RC-2016-RN-00699-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00699-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Johnson & johnson medical pty. ltd. (jjm) is issuing a medical device recall, in line with an ethicon initiated worldwide medical device removal, of ethicon physiomesh flexible composite mesh (for laparoscopic use).The product is being removed following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
  • 조치
    Johnson & Johnson Medical advises customers to inspect stocks and immediately quarantine any affected units prior to their return. The management of patients who have been treated using ETHICON PHYSIOMESH Composite Mesh will remain at the discretion of the treating health care practitioner. A Hazard alert letter will be sent to Surgeons.

Device

Ethicon Physiomesh Flexible Composite Mesh
  • 모델명 / 제조번호(시리얼번호)
    Ethicon Physiomesh Flexible Composite MeshAll Product Codes and Lot Numbers affectedARTG Number: 182785
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd