FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2981864
·
Received February 27, 2013
Report
- Report Number
- 9616091-2013-00317
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- January 31, 2013
- 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
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CALLER ,THE LITTLE CHROME PIECE WITH THE BUTTON ON IT IS MISSING FROM THE BAR THAT RUNS BEHIND THE HEAD REST . MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83748 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | TRSX5RC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |