Events

PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Culpan Medical 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-00865-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00865-1
  • 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
    It was identified that the phil container (syringe) may elute unintended elements (metals) into phil device formulation. this elution may discolour the phil device, or may not change the appearance of the device. at this point no adverse events related to product deficiency or specific patient reactions were reported to the manufacturer. microvention has not currently identified possible risk to patients associated with previous uses of phil devices. culpan medical is in negotiations with the tga regarding the need for any further actions.
  • 조치
    Customers are advised to identify and quarantine all affected devices in their possession and return them to Culpan Medical. Recommended patient follow-up for doctors: continue to collect and report to the Therapeutic Goods Administration and the manufacturer any Adverse Events/Patient Reactions. This action has been closed-out on 10/05/2017.

Device

PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended fo...
  • 모델명 / 제조번호(시리얼번호)
    PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)Product Codes: LEN10250, LEN10300, LEN10350All Batch Numbers affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Culpan Medical Pty Ltd

Manufacturer

Culpan Medical Pty Ltd