FDA Adverse Event
Injury
Summary report: N
CATALYST 5VX
MDR report key: 16010107
·
Received December 19, 2022
Report
- Report Number
- 3005905321-2022-00003
- Event Type
- Injury
- Date Received
- December 19, 2022
- Manufacturer
- KI MOBILITY, LLC
- Product Code
- IOR
- PMA / PMN Number
- K062660
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
END USER'S HUSBAND CLAIMS THE WHEELS KEEP COMING OFF THE WHEELCHAIR AND HIS WIFE HAS INJURED HER LEG. INJURY HAPPENED WHEN FALLING OUT OF CHAIR BECAUSE WHEEL FELL OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2192181 | CATALYST 5VX | MECHANICAL WHEELCHAIR | IOR | KI MOBILITY, LLC | CATALYST 5VX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |