inforMED
InjuryIOR

DRIVEMEDICAL

Received Oct 26, 2025 · Event occurred Sep 19, 2025

Report 3007309323-2025-00056 · MDR key 23387834

Device

Generic name

Wheelchair, Mechanical, Product Code: Ior

Model number

CX418ADDA-ELR

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • Laceration(s)
  • Concussion
  • Convulsion/Seizure
  • Laceration(s)
  • Concussion
  • Convulsion/Seizure

Narrative

Description of Event or Problem

DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY THE PROVIDER WHO STATED THE END USER WAS SITTING IN THE WHEELCHAIR AND A WHEEL BROKE CAUSING THE END USER TO FALL TO THE FLOOR. THE END USER WAS HOSPITALIZED WITH A CONCUSSION, SEIZURES, AND A FOREARM SKIN TEAR. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

Remedial action

  • Repair
  • Inspection