BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 4957012 · Received July 31, 2015

    Report

    Report Number
    1525712-2015-04089
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 8, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE PROVIDER STATES THE BACK BRACKET IS BROKEN AND LATERAL ON THE LEFT SIDE ARE BROKEN AS WELL AS THE ARMPADS BEING HELD ON BY DUCT TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501754 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other