Events

AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbvie 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-2017-RN-00619-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00619-1
  • 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
    Abbvie has identified the potential for missing components and / or duplicate components in the abbvie peg 15 r and abbvie j intestinal tube 9 fr for peg 15 fr kits. the reported events of missing components have not been associated with any reports to abbvie of related serious injury and it is unlikely for the missing components to pose any significant safety risk.
  • 조치
    AbbVie is advising users to inspect the kits using the product’s Instructions for Use, product description section to ensure all components are present before proceeding with implantation. Any missing components are to be reported to AbbVie, including details of the device lot number, and the kit returned to AbbVie. AbbVie will provide replacement kits if there are missing components.

Device

AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used ...
  • 모델명 / 제조번호(시리얼번호)
    AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)AbbVie PEG 15 R Product Code: 62941-001AbbVie J Intestinal Tube 9 FR for PEG 15 FR Product Code: 62943-001All lots may be affected.ARTG Numbers: 223443 and 223444
  • Manufacturer
    Abbvie Pty Ltd

Manufacturer

Abbvie Pty Ltd