FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3222831
·
Received July 12, 2013
Report
- Report Number
- 1525712-2013-05682
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Report Date
- June 21, 2013
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER REPORTED THE SEAT UPHOLSTERY ON THE TREX2 IS SAGGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322845 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | TREX2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |