FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3954414
·
Received July 24, 2014
Report
- Report Number
- 9616091-2014-01281
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Report Date
- June 17, 2014
- Manufacturer
- INVAMEX
- 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
DEALER STATES THE FRAME ON THE RIGHT SIDE IS BROKEN AT THE WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434677 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | TREX28R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |