BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5884250 · Received August 17, 2016

    Report

    Report Number
    8022077-2016-00057
    Date Received
    August 17, 2016
    Date of Event
    April 26, 2016
    Report Date
    August 17, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST TIME WE HAVE AN ISSUE OF THE SORT OF THE SHORT GREY METAL TUBE INSIDE THE REAR RIGHT LEG BREAKING IN HALF. THIS IS AN ISOLATED OCCURRENCE. WE WILL MONITOR THIS CLOSELY BUT FOR NOW THIS IS THE FIRST INCIDENT OF THE SORT. WE SENT THE CUSTOMER A NEW REPLACEMENT UNIT. THE BROKEN UNIT WAS NEVER SENT HERE FOR INVESTIGATION. THIS CASE IS NOW CLOSED.

    Description of Event or Problem · 1

    THE SHORT GREY METAL TUBE INSIDE THE REAR RIGHT LEG BROKE IN HALF. THE CUSTOMER WAS WALKING, SHE FELL BUT NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535860 HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR