BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 6130336 · Received November 28, 2016

    Report

    Report Number
    8022077-2016-00127
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 28, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FELL ON THE ROLLING WALKER AND SCRAPPED HER KNEE ON THE BRAKE. THERE WAS NO INDICATION THAT THE FALL WAS DUE TO THE PRODUCT MALFUNCTIONING. WE RECEIVED PICTURES ILLUSTRATING THAT THE UNIT WAS NOT BROKEN. THIS CASE IS NOW CLOSED AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER WAS WALKING USING THE ROLLING WALKER WHEN SHE FELL ON THE WALKER AND SCRAPPED HER KNEE ON THE BRAKE. SHE WAS TAKEN TO THE HOSPITAL SINCE THE CUT WAS DEEP.THERE WAS NO INDICATION OF A PRODUCT DEFECT AND THE PRODUCT DID NOT CONTRIBUTE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779699 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization