FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4033650
·
Received August 25, 2014
Report
- Report Number
- 1525712-2014-04965
- Event Type
- Malfunction
- Date Received
- August 25, 2014
- Report Date
- July 28, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- 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
THE END USER STATES THE FRONT FORK ON HIS DAUGHTERS CHAIR IS BROKEN. HE STATES THEY WERE IN A RESTAURANT AND THE FORK DISINTEGRATED. THE END USER STATES THEY HAVE A MULTITUDE OF CAREGIVERS WHO TAKE CARE OF HIS DAUGHTER AND SOME OF THEM ARE NOT SO GENTLE ON THE CHAIR. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514369 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET | SPREE3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |