BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDESTEPPER ADULT

    MDR report key: 2171880 · Received March 10, 2007

    Report

    Report Number
    3006112083-2007-00009
    Event Type
    Malfunction
    Date Received
    March 10, 2007
    Date of Event
    February 20, 2007
    Report Date
    March 7, 2007
    Manufacturer
    PROFIT COUNTRY ENTERPRISES
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DEALER SAID, "THE RIGHT LEG CLOSEST TO THE USER BUCKLED WHEN THE USER WAS GETTING UP FROM A CHAIR". THE USERS LEFT ELBOW WAS SCRAPED AND A SMALL BRUISE WHEN THE ELBOW LANDED AGAINST A WALL." "NO MEDICAL TREATMENT WAS SOUGHT WHEN ASKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDESTEPPER ADULT SIDESTEPPER ITJ PROFIT COUNTRY ENTERPRISES 07770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other