Events

Safety Alert for Clavos de Kirschner INNOMED

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Innomed 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
    R1711-546
  • Event Number
    2009DM-0003484
  • Date
    2017-11-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=63
  • 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 he has received the report of an adverse event that caused the doubling of the referenced device, this situation could lead to the repetition of potential adverse events on the patients.

Device

Clavos de Kirschner INNOMED
  • Model / Serial
    I09CK1823, lot 0417-4674
  • Product Description
    Osteosynthesis system for surgical treatment of fractures in the appendicular skeleton, in which these are reduced and fixed in a stable manner. With the aim of returning the anatomy and function to the skeletal segment injured, while the healing of the fracture is obtained.
  • Manufacturer
    Innomed S.A

Manufacturer

Innomed S.A
  • Source
    NIDFSINVIMA