FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2981870
·
Received February 27, 2013
Report
- Report Number
- 1525712-2013-01510
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- January 31, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER THE PIN ON THE BACK CANES SHEARED OFF AND THE CANES BROKE IN HALF. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83750 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE TAYLOR STREET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |