FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 3011796
·
Received March 19, 2013
Report
- Report Number
- 9615350-2013-00005
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Report Date
- February 20, 2013
- Manufacturer
- MOTION CONCEPTS
- Product Code
- KNN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THE BACK SHELL IS CRACKED AND HARDWARE IS FALLING OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115070 | WHEELCHAIR COMPONENTS | 890.3920 | KNN | MOTION CONCEPTS | MPB1616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |