FDA Adverse Event
Malfunction
Summary report: N
TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX
MDR report key: 4414059
·
Received January 13, 2015
Report
- Report Number
- 1525712-2015-00294
- Event Type
- Malfunction
- Date Received
- January 13, 2015
- Report Date
- December 30, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- 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 STATES THAT THE LNX LEG ACTUATOR BENT AND GEAR SCREWED OUT. NO FURTHER INFORMATION IS AVAILABLE. UNABLE TO ACCESS PROTOCOL QUESTIONS UNABLE TO ATTACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30562 | TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |