BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3250939 · Received July 29, 2013

    Report

    Report Number
    9616091-2013-01343
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 11, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CROSSBRACE ON THE TRSX52FB WHEELCHAIR HAS BROKEN AT THE WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352578 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX52FB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 Other