Events

Safety Alert for Temperature Management System ARCTIC SUN

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medivance, Inc || Productos para el Cuidado de la Salud || Dymax 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
    R1603-121
  • Event Number
    2014EBC-0011551
  • Date
    2016-03-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 it has identified the possibility of loss of water circulation in the referenced pads, leading to potentially adverse events occurring on patients.

Device

Temperature Management System ARCTIC SUN
  • Model / Serial
    Concerning the pads, reference ARCTICGEL PADS, specific lots.
  • Product Description
    The ARCTIC SUN temperature management system has been designed to monitor and control the patient's temperature. The ARCTICSUN temperature management system is composed of the ARCTICSUN control module and non-sterile ARCTICGEL disposable pads, which attach to the areas of the patient's skin.
  • Manufacturer
    Medivance, Inc || Productos para el Cuidado de la Salud || Dymax Corporation

Manufacturer

Medivance, Inc || Productos para el Cuidado de la Salud || Dymax Corporation
  • Source
    NIDFSINVIMA