BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 8588505 · Received May 7, 2019

    Report

    Report Number
    3001949129-2019-00003
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR'S NOTES RECEIVED. THERE IS NO CONFIRMED REPORTED HISTORY OF INFECTION RELATED TO OUR PRODUCT. WE ARE UNABLE TO CONFIRM IF THE REPORTED INFECTION WAS CAUSED BY OUR DEVICE.

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER CONTACTED US THAT HER FATHER WAS TREATED FOR A UTI WITH ANTIBIOTICS, WHILE USING OUR PRODUCT. DOCTOR'S NOTES WERE REQUESTED, BUT WE INITIALLY RECEIVED PRIOR NOTES INDICATING PATIENT USED A DIFFERENT TYPE OF CATHETER. NOTES ALSO INDICATE RECURRENT UTI'S AND HOSPITALIZATIONS. NOTES WERE RECEIVED ON 5/6/2019 FOR A HOSPITALIZATION ON (B)(6) 2019. PATIENT WAS ADMITTED DUE TO HIM REQUIRING IV ANTIBIOTICS FOR UTI. NOTES FROM THE HOSPITAL DOCTOR MENTION URINARY TRACT INFECTION WITH ESBL, URINARY INCONTINENCE AND NEUROGENIC BLADDER WITH EXTERNAL CATHETER, PRIOR HISTORY OF UTI'S, AND THAT HOME HEALTH SERVICES SUCH AS NURSING AND THERAPY ARE "MEDICALLY NECESSARY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378326 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 E05601

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization