BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEEL ROLLING WALKER

    MDR report key: 6159995 · Received December 9, 2016

    Report

    Report Number
    3012316249-2016-00008
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 9, 2016
    Manufacturer
    COM-BRIDGE INTERNATIONAL CO., LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    THE END-USER BOUGHT THE UNIT AND TWO WEEKS AFTER THE UNIT WAS BOUGHT, THE LEG BENT AND THE END-USER FELL. THE END-USER WAS PUSHING THE UNIT, AND FELL OUTSIDE ON THE CONCRETE SIDEWAY. AN AMBULANCE HAD TO BE CALLED TO HELP HIM GET BACK UP. PER THE END-USER, HE WAS NOT INJURED, AND THE EMT'S HELPED TO GET HIM UP AND BACK INTO THE HOUSE. THE END-USER COMPLAINED OF LEG PAIN IN BOTH LEGS. AFTER ABOUT 2 HOURS, THE PAIN WENT AWAY. THE END-USER IS REPORTED TO MOSTLY USE THE ROLLATOR OUTSIDE - THE USER WAS WALKING TO HIS TRUCK, WHEN THE FRONT WHEEL BUCKLED AND HE FELL. HE ALSO USES THE ROLLATOR FOR BALANCE, AND ONCE IN AWHILE, HIS LEG GIVES OUT ON HIM, SO THE ROLLATOR IS HELPFUL. THE DEVICE WAS RETURNED TO (B)(4) ON 12/8/2016 & REVIEWED ON 12/9/2016 - THE UNIT WAS FOUND TO HAVE A BENT FRONT CASTER WHEEL, AND THE TUBING OF THE WHEEL THAT SLIDES INTO THE FRAME WAS FOUND TO ALSO HAVE BENT, RESULTING IN THE UNIT BEING UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809816 STEEL ROLLING WALKER ROLLATOR ITJ COM-BRIDGE INTERNATIONAL CO., LTD FGA22100 0000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention