FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 3935964
·
Received July 15, 2014
Report
- Report Number
- 1525712-2014-03705
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 9, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
FACILITY ADVISED LEFT FOOTPLATE IS BROKEN. NO INJURY. FACILITY COULD NOT PROVIDE ANY FURTHER INFORMATION. (B)(6)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414435 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | M94-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |