BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5843074 · Received August 3, 2016

    Report

    Report Number
    8022077-2016-00060
    Date Received
    August 3, 2016
    Report Date
    August 2, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INJURY SUSTAINED AND NO AMBULANCE WAS REQUIRED AT THE TIME OF THE INCIDENT. THE LADY FELL BUT THERE WAS NO INJURY. WE CONTACTED THE CUSTOMER AND REPLACED THE UNIT FREE OF CHARGE. 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 BE 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 UNIT WAS NEVER RECEIVED HERE FOR INVESTIGATION. NO CAPA WAS DONE AS THE COMPLAINT RATIO IS SIGNIFICANTLY LOW BASED ON THE AMOUNT OF UNITS SOLD PER YEAR. THE CLAIM IS CLOSED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SHE WAS SEATING ON THE SEAT OF THE ROLLING WALKER WHEN IT BROKE UNDER THE WELDING PART. SHE FELL BUT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496150 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR