FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3821833
·
Received May 20, 2014
Report
- Report Number
- 1525712-2014-02543
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Report Date
- April 8, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
END USER STATED THAT THEIR TDXSP-CG POWER CHAIR WAS UNCONTROLLABLE, CHAIR HIT A CEMENT WALL AT SCHOOL. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300264 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-CG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 | Other |