BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4121810 · Received September 26, 2014

    Report

    Report Number
    9616091-2014-01995
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 5, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REP STATES THE FRONT CASTER CRACKED WHEN THE END USER HIT A CRACK IN THE SIDEWALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602100 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other