FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 4211310
·
Received October 29, 2014
Report
- Report Number
- 9616091-2014-02288
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Report Date
- October 9, 2014
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
TECHNICIAN FOR VA CALLED AND ADVISED BOTH WHEELS ARE BENT CAUSING THEM TO WOBBLE ON T4. TECHNICIAN ADVISED LOOKS LIKE RIGHT SIDE TIRE IS NOT SEATED ALL THE WAY IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693676 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | T4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |