BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 5595470 · Received April 21, 2016

    Report

    Report Number
    8022077-2016-00028
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    March 19, 2016
    Report Date
    April 21, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER FELL BUT THERE WAS NO SERIOUS INJURY AND NO AMBULANCE WAS REQUIRED. WE SHIPPED A NEW ROLLING WALKER TO THE CUSTOMER AND REQUESTED THAT THE DEFECTIVE UNIT BE SENT TO US FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE WHEEL OF THE ROLLING WALKER SHE USES IN HER HOME TO GET AROUND HAD THE WHEEL SEEMINGLY SHEER OFF. SHE FELL AND THE METAL EXPOSED FROM THE WHEEL GASHED HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248834 HUGO HUGO ELITE ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other