BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3103365 · Received May 9, 2013

    Report

    Report Number
    1525712-2013-03645
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES UND USER SNAPPED THE RIGHT BOLTS THAT HOLD THE LEGREST ATTACHING HARDWARE. HE PUTS ALL HIS WEIGHT ON THE RIGHT HAND SIDE BECAUSE OF HIS CONDITION AND THE PRESSURE OVER TIME SNAPPED THE BOLTS PER THE DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203128 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other