FDA Adverse Event
Malfunction
Summary report: N
KI MOBILITY, LLC
MDR report key: 22921437
·
Received August 29, 2025
Report
- Report Number
- 3005905321-2025-00006
- Event Type
- Malfunction
- Date Received
- August 29, 2025
- Date of Event
- August 15, 2025
- Report Date
- August 28, 2025
- Manufacturer
- KI MOBILITY, LLC
- Product Code
- IOR
- UDI-DI
- 00850013379323
- PMA / PMN Number
- K062660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DEALER STATES THAT THE CAMBER TUBE ASSEMBLY SNAPPED ON THE END USERS CHAIR WHILE IN THE CHAIR. HE WAS IN CHAIR GOING DOWN HIS HALLWAY WHEN THE CAMBER TUBE SNAPPED AND HE FELL OUT OF CHAIR INJURING HIS RIGHT INSIDE ELBLOW. HE WENT TO THE ER ON FRIDAY, (B)(6) 2025. INJURY REPORTED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2838069 | KI MOBILITY, LLC | ROGUE2 | IOR | KI MOBILITY, LLC | ROGUE2 | 00850013379323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Other |