Events

Safety Alert for Electrodes for Electroencephalography Registration

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by The Electrode Store, Inc.

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
    R1708-353
  • Event Number
    2012DM-0008840
  • Date
    2017-10-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=67
  • 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
    It is reported by the importer that the referenced devices were conditioned with a labeling that does not correspond to him, because of an official of the company, which is why the product is withdrawn from the market in a preventive manner, as it does not comply with the requirements of the technical and legal provisions regulating it are considered as fraudulent products.

Device

Electrodes for Electroencephalography Registration
  • Model / Serial
    PRO-37SAF, lot 0137093.
  • Product Description
    Neurodiagnostic record of electroencephalography, electromyography, evoked potentials.
  • Manufacturer
    The Electrode Store, Inc

Manufacturer

The Electrode Store, Inc
  • Source
    NIDFSINVIMA