BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3232994 · Received July 18, 2013

    Report

    Report Number
    9616091-2013-01244
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE UPPER SUPPORT BROKE AND THE FRONT RIGGINGS ARE NOT LATCHING ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334457 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other