BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4912873 · Received July 14, 2015

    Report

    Report Number
    9616091-2015-01829
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    June 19, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DEALER STATES THAT THE RIGHT SIDE CASTER IS CATCHING ON THE FRONT RIGGING WHEN THE END USER IS MAKING A RIGHT HAND TURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455308 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other