BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM DESIGN GIZMO

    MDR report key: 594592 · Received April 22, 2005

    Report

    Report Number
    2081283-2005-00001
    Event Type
    Injury
    Date Received
    April 22, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 21, 2005
    Manufacturer
    FREEDOM DESIGNS, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE IS A MANUAL WHEELCHAIR WITH A TILT IN SPACE FEATURE. DEALER NOTIFIED MANUFACTURER REGARDING A CLIENT WHO HAD ADVISED THAT PT HAD MANGED TO TIP OVER THE DEVICE. AS THE DEVICE FELL OVE IT KNOCKED A TV OFF A NIGHT STAND AND ONTO THE PT. THIS RESULTED IN AN INJURY THAT REQUIRED 8 STITCHES TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM DESIGN GIZMO 890.3850 IOR FREEDOM DESIGNS, INC. GZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention