FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3130129
·
Received May 24, 2013
Report
- Report Number
- 9616091-2013-00887
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Report Date
- May 1, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ADVISED THE CASTER FORK BEARINGS ARE FROZEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230815 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | 9XDT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |