Events

Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Dynamx Australia T/a Macmed Healthcare 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-01570-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01570-1
  • 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
    There is the potential of defective labels on the printed mattress covers at the foot of the mattress. these defective labels may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
  • 조치
    MacMed is requesting customers to quarantine affected stock which have not been used. Collection of affected products and replacement with unaffected goods will take place as soon as possible. For customers with mattresses already in use, MadMed will visit these customers to inspect if they have affected stock which requires replacing.

Device

Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between ...
  • 모델명 / 제조번호(시리얼번호)
    Medical Mattresses and Mattress CoversAffected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016ARTG Number: 107808
  • Manufacturer
    Dynamx Australia T/a Macmed Healthcare

Manufacturer

Dynamx Australia T/a Macmed Healthcare