Events

Safety Alert for Wheelchair

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Otto Bock Mobility Solutions GMBH.

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
    I1404-162
  • Event Number
    2013DM-0010718
  • Date
    2014-04-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=204
  • 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 informs about the possible risk of rupture of the forks of the front wheels when colliding them against the edges of the streets, leading to the occurrence of adverse events on the patient.

Device

Wheelchair
  • Model / Serial
    OTTO BOCK A200, SKIPPI AND WHEELCHAIRS SKIPPI
  • Product Description
    Technical help to allow the displacement of people with locomotion problems or reduced mobility due to an injury.
  • Manufacturer
    Otto Bock Mobility Solutions GMBH

Manufacturer

Otto Bock Mobility Solutions GMBH