BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5880133 · Received August 16, 2016

    Report

    Report Number
    8022077-2016-00056
    Date Received
    August 16, 2016
    Report Date
    August 16, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER DID NOT FALL AND THERE WAS NO INJURY. WE SENT THE END-USER A REPLACEMENT ROLLING WALKER TO HER HOME. THIS IS AN 8 YEARS OLD ROLLATOR AND WE DO NOT KNOW IF IT WAS EVER USED AS A TRANSPORT CHAIR. WE HAVE DONE ALL SORTS OF CORRECTIVE ACTIONS ON THIS PARTICULAR UNIT OVER THE YEARS AND HAVE CLEAR VISIBLE WARNING LABELS ON THE UNIT STATING THAT IT SHOULD NOT USED AS A TRANSPORT CHAIR. EVEN WITH THE VISIBLE WARNINGS, CUSTOMERS STILL USE THE ROLLING WALKER AS A TRANSPORT CHAIR. THIS COULD CONTRIBUTE TO THE BREAKAGE OF THE UNIT. THE CLAIM IS NOW CLOSED.

    Description of Event or Problem · 1

    CUSTOMER WAS USING THE ROLLING WALKER AT A STORE AND THE FRAME BROKE. SHE CAUGHT HERSELF AND DID NOT FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532632 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR