FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 4111590
·
Received September 23, 2014
Report
- Report Number
- 1525712-2014-06218
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 29, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
UNKNOWN MALFUNCTION. FIRST JOYSTICK FOR THIS UNIT REPLACED EITHER (B)(6) OF 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591454 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSIV-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |