BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 7379500 · Received March 28, 2018

    Report

    Report Number
    8022077-2018-00110
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    May 6, 2016
    Report Date
    March 28, 2018
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    KHY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WE DID NOT RECEIVE MORE INFORMATION REGARDING THE CANE. WE ASKED THE CUSTOMER TO SEND US PICTURES OF THE BROKEN CANE BUT NEVER RECEIVED ANY PICTURES. AN INVESTIGATION COULD NOT BE DONE ON THE UNIT SINCE IT WAS NEVER SENT TO OUR HEAD OFFICE. THIS IS CONSIDERED AN ISOLATED OCCURRENCE UNTIL WE RECEIVE FURTHER INFORMATION. A FINAL REPORT WILL BE SUBMITTED ONCE WE RECEIVE MORE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER WALKED ABOUT 10 STEPS FROM HER BEDROOM TO HER BATHROOM USING THE CANE. IN THE BATHROOM, THE CANE SNAPPED/BROKE AND CAUSED THE CUSTOMER TO FALL AND HIT HER HEAD KNOCKING HER UNCONSCIOUS. SOME TIME LATER, SHE WAS FOUND UNCONSCIOUS AND TAKEN TO THE HOSPITAL VIA AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219610 HUGO AQUA OFFSET CANE KHY AMG MEDICAL INC. 731-859

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization