BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5947595 · Received September 13, 2016

    Report

    Report Number
    8022077-2016-00065
    Date Received
    September 13, 2016
    Date of Event
    July 18, 2016
    Report Date
    September 13, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER FELL AND WAS ONLY SORE. WE SENT THE END-USER A REPLACEMENT ROLLING WALKER TO HER HOME. WE HAVE CLEAR VISIBLE WARNING LABELS ON THE UNIT STATING THE FOLLOWING: DO NOT NAVIGATE THE ROLLING WALKER WHILE SITTING ON THE SEAT. THE BRAKES SHOULD ALWAYS BE LOCKED WHEN THE SEAT IS BEING USED. RISK OF FALL OR SERIOUS INJURY MAY RESULT IF BRAKES ARE NOT LOCKED WHILE USER IS SITTING ON THE SEAT. THIS CASE IS NOW CLOSED.

    Description of Event or Problem · 1

    CUSTOMER WAS SITTING IN THE SEAT OF THE ROLLING WALKER AND ROLLED HERSELF TO HER DESK (6-7 FEET AWAY). THE FRAME OF THE ROLLING WALKER BROKE AND SHE FELL TO THE FLOOR. THERE WAS NO INJURY AND SHE WAS ONLY SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598450 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1