FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3260093
·
Received August 1, 2013
Report
- Report Number
- 1525712-2013-06438
- Event Type
- Malfunction
- Date Received
- August 1, 2013
- Report Date
- July 18, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A SOLARA2G MANUAL WHEELCHAIR HAD THE FRONT RIGGING 3" EXTENSION TUBE ROUNDED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360976 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | ITI | INVACARE TAYLOR STREET | SOLARA2G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |