FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 4093106
·
Received September 16, 2014
Report
- Report Number
- 1525712-2014-05896
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- September 21, 2014
- Manufacturer
- UNKNOWN
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ADVISED AFTER RECEIVING THE RELEASE HANDLE SHE WAS TOLD BY HER CUSTOMER THAT THE ORIGINAL HANDLE WAS MANGLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572982 | POWERED WHEELCHAIR | 890.3860 | ITI | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |