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