Events

Safety Alert for urological use guide Urodrain Promedon

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

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
    R1706-242
  • Event Number
    2016DM-0003731-R1
  • Date
    2017-06-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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 has identified that there is a decrease in the hydrophilic property of the product due to exposure to temperatures outside of specification during the importation process, leading to the potential occurrence of adverse events on the patients.

Device

urological use guide Urodrain Promedon
  • Model / Serial
  • Product Description
    A guide product to locate the urethral stent inside the ureter.
  • Manufacturer
    Promedon S.A.

Manufacturer

Promedon S.A.