BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5780484 · Received July 9, 2016

    Report

    Report Number
    8022077-2016-00042
    Date Received
    July 9, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 8, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER BRUISED HIS HIPS WHEN HE FELL BUT NO AMBULANCE WAS REQUIRED AND HE DID NOT GO TO THE HOSPITAL. WE SENT THE END-USER A REPLACEMENT ROLLING WALKER TO HIS HOME. THIS IS A REVISION 2.5 ROLLING WALKER MANUFACTURED IN 2007 THEREFORE 12 YEARS OLD. WE HAVE DONE ALL SORTS OF CORRECTIVE ACTIONS ON OUR ROLLATORS THROUGHOUT THE YEARS AND DO NOT HAVE ISSUES WITH OUR NEW REVISION NUMBERS. THIS CASE IS NOW CLOSED.

    Description of Event or Problem · 1

    CUSTOMER FELL AND HIT HIS HEAD WHEN THE WHEEL BROKE OFF. HE WAS WALKING INSIDE HIS HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434980 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR