FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3000658
·
Received March 12, 2013
Report
- Report Number
- 9616091-2013-00431
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Report Date
- February 15, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES BOTH CROSSBRACES ARE BROKEN IN MIDDLE. PER DEALER, END USER IS ROUGH ON THE CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104204 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | 9SL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |