FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3243412
·
Received July 23, 2013
Report
- Report Number
- 1525712-2013-06059
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Report Date
- July 2, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PIVOT ON THE TDXSP POWERED WHEELCHAIR CAME OFF DUE TO A MISSING WELD TAC POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343443 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |