BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3964415 · Received July 29, 2014

    Report

    Report Number
    1525712-2014-04083
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 25, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, THE HAND RIM KEEPS COMING OFF OF THE WHEEL. HE STATES THE NUTS ARE COMING OFF OF THE RIM CAUSING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440806 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET MVPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other