Events

Licox 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Integra Neurosciencies Implants France Sas || Gms, Gesellschaft Fur Medizinische Sondentechnik Mbh || Integra Lifesciencies Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1502-96
  • 사례 연번
    2014DM-0012300
  • 날짜
    2015-02-27
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=184
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that there is a possibility that the pbto² readings may be incorrect due to a smart card improperly programmed when using the referenced catheters, leading to the generation of possible adverse events on the patient.

Device

Licox
  • 모델명 / 제조번호(시리얼번호)
    Oximetry measurement catheters, reference Class IV - CC1.P1, serial 260 614.
  • 제품 설명
    The LICOX® brain tissue oxygen monitoring system, probes and introducers, also known as the LICOX® core pressure and temperature oxygen pressure monitoring probes and their introducers, are sterile invasive single-use devices for monitoring the viability of the tissue through of the measurement and monitoring of partial pressure of oxygen and temperature in tissues (PtO²). The system of devices LICOX ® braintissue oxygen monitoring probes and introducers are adaptable to applications of monitoring the partial pressure of oxygen and temperature of brain tissue and tissues in plastic and reconstructive surgery. The LICOX ® braintissue oxygen monitoring system introducers are indispensable for the placement of the monitoring probes and are specific as they are only indicated for the placement of the probes. The LICOX® brain tissueoxygen monitoring system probes and introducers are flexible micro-catheters used for short-term monitoring (5 days maximum use) of oxygen partial pressure (PtO²) in brain tissue and other tissues such as soft tissues, which are directly introduced in the tissues by means of their introducer kits and they are connected to the LICOX ® brain tissue oxygenmonitors by means of specific cables (the monitors will be registered in a separate register).
  • Manufacturer
    Integra Neurosciencies Implants France Sas || Gms, Gesellschaft Fur Medizinische Sondentechnik Mbh || Integra Lifesciencies Corporation

Manufacturer

Integra Neurosciencies Implants France Sas || Gms, Gesellschaft Fur Medizinische Sondentechnik Mb...
  • Source
    NIDFSINVIMA