BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5952578 · Received September 15, 2016

    Report

    Report Number
    8022077-2016-00066
    Date Received
    September 15, 2016
    Date of Event
    September 11, 2016
    Report Date
    September 15, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE SENT THE END-USER A REPLACEMENT ROLLING WALKER TO HIS HOME. THIS IS A (B)(6) 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

    THE METAL TUBING BROKE OFF CAUSING THE END-USER TO FALL ONTO THE FLOOR. HE BRUISED HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604353 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR