FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3800620
·
Received May 8, 2014
Report
- Report Number
- 1525712-2014-02344
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Report Date
- April 2, 2014
- Manufacturer
- INVACARE
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CROSS BRACE IS BROKEN IN HALF FROM WHAT APPEARS TO BE THE LEFT SIDE CROSS BRACE SUPPORT OF A MVPS MANUAL WHEEL CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278566 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVACARE | MVPS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |