KI
Received Feb 3, 2026 · Event occurred Jun 29, 2024
Report 3005905321-2026-00001 · MDR key 24248835
Device
Product problems
- Use of Device Problem
Patient
16 YR · Female
- Abrasion
Narrative
Additional Manufacturer Narrative
AFTER RETROSPECTIVE REVIEW OF COMPLAINTS, THIS REPORT WILL BE FILED IN ABUNDANCE OF CAUTION BECAUSE RECORD WAS NOT REPORTED. NO ADDITIONAL INFORMATION OR COMMUNICATION WITH THE END USER AFTER THE INITIAL REPORT. REPLACEMENT PARTS WERE PROVIDED. AFTER PRODUCT RETURNED THE FRAME DAMAGE DOES NOT LOOK LIKE NORMAL USE. THIS IS NOT A DEFECTIVE PART.
Description of Event or Problem
THE END USER WAS GOING DOWN A HILL AND LOST CONTROL AND HIT A BUMP AND WAS LAUNCHED FROM THE CHAIR. THE END USER HAD A FACIAL FRACTURE AND LOST SOME TEETH, SOME BRUISING, AND ABRASIONS TO HER HANDS. HOSPITALIZED FOR 3 DAYS WITH MONITORING AND X-RAYS DUE TO MOUTH TRAUMA.