FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4093832
·
Received September 16, 2014
Report
- Report Number
- 9616091-2014-01881
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- August 22, 2014
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USERS CARE GIVER STATED LEFT SIDE REAR WHEEL IS WARN AND DOES NOT HOLD AIR
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571544 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |