BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 6085293 · Received November 6, 2016

    Report

    Report Number
    MW5065866
    Event Type
    Injury
    Date Received
    November 6, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 6, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FELL AND CUT RIGHT LEG BELOW KNEE ON METAL FLANGE OF THE BREAK. CUT IS TO THE BONE AND IS OVER 6 INCHES LONG. CUT SKIN AND GRAFT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731962 HUGO HUGO ROLLATOR WALKER ITJ AMG MEDICAL INC. P/N000045HU-2

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization