FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3024220
·
Received March 27, 2013
Report
- Report Number
- 1525712-2013-02346
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. END USER ALLEGES THAT THE ARMS ARE CRACKING TO THE POINT OF NOT BEING USABLE WITHOUT REPAIR. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126269 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 | Other |