FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3593725
·
Received January 27, 2014
Report
- Report Number
- 1525712-2014-00504
- Event Type
- Malfunction
- Date Received
- January 27, 2014
- Report Date
- January 17, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Removal / Correction Number
- Z-2270-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BRACKET THAT ATTACHES TO THE ARM TUBE ON A POWERED WHEELCHAIR WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58842 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |