Events

O2Vent T (Mandible-repositioning anti-snoring orthosis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Oventus 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-01572-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01572-1
  • 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
    The manufacturer has determined that a correction to the adjuster assembly part of the o2vent t device is necessary and must be returned for rework. the adjuster assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment. the performance of the device and risk to patient safety is affected by the faulty adhesion of the adjuster assembly part.
  • 조치
    Oventus is advising clinicians to inform the patients that are using the affected product and advise them to stop using the device and arrange for it to be returned to Oventus Manufacturing for rework within 10 days. Also, any remaining devices that are currently in their possession should be also be returned for rework. This action has been closed-out on 01/03/2018.

Device

O2Vent T (Mandible-repositioning anti-snoring orthosis)
  • 모델명 / 제조번호(시리얼번호)
    O2Vent T (Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLDevices manufactured & delivered from 17 Nov 2016ARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd