FDA Adverse Event
Malfunction
Summary report: N
KI MOBILITY, LLC
MDR report key: 23622082
·
Received November 21, 2025
Report
- Report Number
- 3005905321-2025-00007
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 13, 2025
- Report Date
- November 14, 2025
- Manufacturer
- KI MOBILITY, LLC
- Product Code
- IOR
- UDI-DI
- 00850013379323
- PMA / PMN Number
- K223527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DEALER CLAIMS THE BACK UPHOLSTERY BROKE AWAY FROM THE BACK TUBES AND 2 ATTACHING SCREWS ON THE TENSION ADJUSTABLE BACK UPHOLSTERY AND THE CLIENT FELL BACKWARD, HIT THE WALL AND BROKE THRU THE SHEET ROCK AND WAS UNCONSCIOUS, CLIENT WAS ON THE FLOOR FOR AN HOUR UNTIL PARENT CAME TO GET HIM. THE END USER WAS GOING FROM HALL WAY INTO HIS BEDROOM. AS HE WAS PROPELLING, PRESSURE WAS PUT ON THE BACK REST AND HE IS PARALYZED AND DID NOT FEEL THE UPHOLSTERY SLIDING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2024413 | KI MOBILITY, LLC | ROGUE 2 | IOR | KI MOBILITY, LLC | ROGUE 2 | 00850013379323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Other |