FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 2876820
·
Received December 17, 2012
Report
- Report Number
- 9615350-2012-00005
- Event Type
- Malfunction
- Date Received
- December 17, 2012
- Report Date
- November 19, 2012
- Manufacturer
- MOTION CONCEPTS
- Product Code
- IMP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INCORRECT INFORMATION WAS SUBMITTED ON THE INITIAL MEDWATCH.
Description of Event or Problem · 1
DEALER STATES THE BACK MOUNTING HARDWARE HAS BROKEN. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WHEELCHAIR COMPONENTS | 890.3920 | IMP | MOTION CONCEPTS | IMX1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |