Events

Earmoulds in use with children under 36 months 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Starkey Laboratories Australia 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-2018-RN-00474-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00474-1
  • 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
    Starkey have been made aware of a single incident in the uk where an unattended child aged 7 months has required treatment to remove an earmould from the larynx. this is the first reported incident of its kind, the likelihood of such event is considered extremely low and on this occasion there was no long-term injury.There have been no reported incidents in australia relating to this issue.
  • 조치
    Starkey is recommending clinicians glue tubing in place for new mould orders manufactured for children up to the age of 36 months. Clinicians are advised to mark orders with "Glue-inTube" when patients meet this criterion.

Device

Earmoulds in use with children under 36 months

Manufacturer

Starkey Laboratories Australia Pty Ltd