FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3901964
·
Received June 30, 2014
Report
- Report Number
- 1525712-2014-03287
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Report Date
- May 28, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER ALLEGES THE SEAT UPHOLSTERY HAS ISSUE ON A (B)(4) STANDARD WHEELCHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380539 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | TRSX5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |