Events

GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Heraeus Dental 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-2014-RN-00497-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00497-1
  • 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 have received reports about single syringes of these lot showing more than usual jerky extrusion behaviour. in one case this led to a fluid ejection from the syringe in front of a hygienist when pushing harder on the plunger rod outside the mouth. if uncontrolled fluid ejection from the syringe occurs, especially the dental patient could be exposed to the gel reaching the mucosa, the face or even the eyes causing irritation, chemical burns and blistering of the tissues which is a medically reversible condition.
  • 조치
    Customers are advised to search their inventory and immediately quarantine any GLUMA Desensitizer PowerGel stock with the affected lot numbers. Stop using the affected products and return the product to the distributor. This action has been closed-out on 11/02/2016.

Device

GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent)
  • 모델명 / 제조번호(시리얼번호)
    GLUMA Desensitizer Power Gel ( Polymer based dental bonding agent)Article Numbers: 66043451, 66052803Syringe Lot Numbers: 10103, 10104Assortment Lot Numbers: 42, 43, 44, 45, 46, 47, 48, 49, 50, 51Expiry Date: 09/2015ARTG number: 92714
  • Manufacturer
    Heraeus Dental Australia Pty Ltd

Manufacturer

Heraeus Dental Australia Pty Ltd
  • Source
    DHTGA