FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3350967
·
Received September 16, 2013
Report
- Report Number
- 1525712-2013-07839
- Event Type
- Malfunction
- Date Received
- September 16, 2013
- Report Date
- September 9, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CROSSBRACE ON A 9XT MANUAL WHEELCHAIR BROKE AT THE BOLT WHERE THE CHAIR FOLDS UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464797 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |