Events

Safety Alert for optical laryngoscope Airtraq

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Prodol Meditec Limited.

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
    I1705-166
  • Event Number
    2010DM-0006816
  • Date
    2017-05-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=89
  • 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 because the two models are very similar, only the avant is compatible with magnetic resonance (mr), therefore institutions that have the two models could use the sp model in an mr environment being pulled by the resonator magnet, the above could lead to possible adverse events on the patient, the user and damage to the resonator.

Device

optical laryngoscope Airtraq
  • Model / Serial
  • Product Description
    The AIRTRAQ is an optical laryngoscope to help the introduction of an endotracheal tube through the patient's vocal cords.
  • Manufacturer
    Prodol Meditec Limited

Manufacturer

Prodol Meditec Limited