FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4170982
·
Received October 14, 2014
Report
- Report Number
- 3002416487-2014-00109
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Report Date
- September 25, 2014
- Manufacturer
- INVACARE CANADA KIRKLAND
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER DEALER, BOTH RIGHT AND LEFT BRAKE HANDLE EXTENSION BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650830 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE CANADA KIRKLAND | MYON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |