FDA Adverse Event
Malfunction
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 3953064
·
Received July 23, 2014
Report
- Report Number
- 1525712-2014-03998
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- UNKNOWN
- Product Code
- KNN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATES THE COMPOSITE FOOTPLATES ON THE FOOTREST ARE BROKEN WHERE IT ATTACHES TO THE PIVOT TUBE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430093 | WHEELCHAIR COMPONENTS | 890.3920 | KNN | UNKNOWN | T94HE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |