BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 4943527 · Received July 17, 2015

    Report

    Report Number
    8022077-2015-00008
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    October 10, 2014
    Report Date
    July 16, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR PHONE DISCUSSION WITH THE CLAIMANT, IT HAS BEEN A COUPLE OF YEARS THAT SHE WAS USING THE WALKER AND SHE USES IT QUITE OFTEN. THE SNAPPING OF THE LEG COULD HAVE BEEN CAUSED BY METAL FATIGUE OVER THE YEARS. OUR REGULATORY DEPARTMENT CONTACTED THE CLAIMANT AND REQUESTED THAT PICTURES BE SENT OVER OF THE WALKER AND THE WALKER RETURNED TO AMG. NO PICTURES WERE EVER PROVIDED AND THE ROLLING WALKER WAS NEVER RETURNED.

    Description of Event or Problem · 1

    CLAIMANT FELL DOWN OUTSIDE AS SHE WAS TAKING A WALK, AND THE LEG OF THE WALKER SNAPPED. CLAIMANT WAS IN PAIN AS SHE HURT HER WRIST AND HER BACK. IF THE LEG SNAPPED AFTER THE FALL, IT MAY BE CAUSED BY A SHOCK. NO AMBULANCE WAS REQUIRED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466759 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR