FDA Adverse Event
Malfunction
Summary report: N
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
MDR report key: 4556273
·
Received March 2, 2015
Report
- Report Number
- 1525712-2015-01492
- Event Type
- Malfunction
- Date Received
- March 2, 2015
- Report Date
- February 23, 2015
- 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 CALLED STATING THAT HE HAD ALREADY ORDERED A MOTOR ACTUATOR FOR THE LNX, BUT WHEN HE WENT TO INSTALL IT, HE NOTICED THAT THE HARDWARE WAS ALL BENT FROM THE END USER RUNNING INTO ITEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144998 | TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX | WHEELCHAIR, POWERED | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |