BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 4827896 · Received June 3, 2015

    Report

    Report Number
    8022077-2015-00001
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    November 11, 2014
    Report Date
    June 1, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEGAL LETTER WE RECEIVED BY THE PATIENT'S LAWYER ON 05/14/2015 WAS THE INITIAL DATE THAT AMG MEDICAL INC. WAS MADE AWARE OF THE INCIDENT. THE LETTER LACKED IMPORTANT INFORMATION. OUR INSURANCE COMPANY IS IN CONTACT WITH THE PATIENT'S LAWYER SO THAT THE MISSING INFORMATION CAN BE OBTAINED. AS SOON AS AMG MEDICAL INC. BECOMES AWARE OF NEW INFORMATION, A FOLLOW UP REPORT WILL BE SENT IN. THE LAWYER WILL ALSO ADVISE IF THE UNIT IN QUESTION CAN BE RETURNED TO AMG MEDICAL INC. FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT HAD A DOCTOR'S APPOINTMENT. UPON CONCLUSION OF HER VISIT, SHE AND HER SON EXITED THE BUILDING. AS SHE WAS STEPPING OFF THE SIDEWALK ONTO THE PARKING LOT PAVEMENT, THE RIGHT VERTICAL POLE OF HER HUGO ROLLING WALKER 4.0 SNAPPED, CAUSING THE PATIENT TO FALL. THE PATIENT SUFFERED AN INJURY WHEN SHE BROKE HER SHOULDER. THE PATIENT WAS RUSHED TO THE EMERGENCY ROOM BY AMBULANCE AND WAS REQUIRED TO UNDERGO SHOULDER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360669 HUGO FMK AMG MEDICAL INC. 700-959/700-961

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S