FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3036331
·
Received April 4, 2013
Report
- Report Number
- 9615350-2013-00007
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MOTION CONCEPTS
- 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
DEALER STATED THAT THE BRACKET THAT ATTACHES A PBE1916 MATRX ELITE BACK TO AN UNKNOWN WHEELCHAIR BROKE WHERE IT ATTACHES TO THE BACK CANES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138381 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | MOTION CONCEPTS | PBE1916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |