Events

Safety Alert for Licox

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Integra Neurosciencies Implants France Sas || Gms, Gesellschaft Fur Medizinische Sondentechnik Mbh || Integra Lifesciencies Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1502-96
  • Event Number
    2014DM-0012300
  • Date
    2015-02-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=184
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Oximetry measurement catheters, reference Class IV - CC1.P1, serial 260 614.
  • Product Description
    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