FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3821830
·
Received May 20, 2014
Report
- Report Number
- 1525712-2014-02542
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- March 30, 2014
- Report Date
- April 7, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER ALLEGES THE SCREWS ARE COMING OUT CAUSING THE FRONT CASTERS AND LEGREST ARE HARD TO GO UP/DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300294 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | UNKNOWN | TREX2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |