FDA Adverse Event
Injury
Summary report: N
KI
MDR report key: 24248835
·
Received February 3, 2026
Report
- Report Number
- 3005905321-2026-00001
- Event Type
- Injury
- Date Received
- February 3, 2026
- Date of Event
- June 29, 2024
- Report Date
- February 2, 2026
- Manufacturer
- KI MOBILITY, LLC.
- Product Code
- IOR
- UDI-DI
- 00850013379323
- PMA / PMN Number
- K062660
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314107 | KI | ROGUE2 | IOR | KI MOBILITY, LLC. | ROGUE2 | 00850013379323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Female | Hospitalization |