FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2944673
·
Received February 5, 2013
Report
- Report Number
- 9616091-2013-00160
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
PROVIDER STATES FRAME IS BROKEN AT WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47781 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | T4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |