BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 8340415 · Received February 14, 2019

    Report

    Report Number
    3001949129-2019-00001
    Event Type
    Injury
    Date Received
    February 14, 2019
    Report Date
    January 8, 2019
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED HOSPITAL NOTES FROM (B)(6) 2019. NOTES INDICATE THE PATIENT REPORTED BEING SEEN PREVIOUSLY FOR KIDNEY INFECTION AND KIDNEY STONE, RELEASED ON NEW YEAR'S DAY. PATIENT WAS SEEN AT HOSPITAL ON (B)(6) 2019 FOR BLOOD IN URINE. URINE TESTED NEGATIVE FOR INFECTION. HE WAS ADMITTED, OBSERVED, AND DISCHARGED THE SAME DAY. THERE IS NO MENTION OF DEVICE. ATTACHMENT INCLUDED. WE ARE STILL UNABLE TO CONFIRM THAT THE INFECTION COMPLAINT WAS CAUSED BY OUR DEVICE. ATTACHMENT: [(B)(6) HOSPITAL CHART NOTES.PDF].

    Additional Manufacturer Narrative · 1

    REQUESTING DOCTOR'S NOTES FROM HOSPITAL. MEDICAL CHARTS FROM PROVIDER'S OFFICE. ATTACHMENT INCLUDED. THERE IS NO CONFIRMED REPORTED HISTORY OF INFECTION RELATED TO OUR PRODUCT. WE ARE UNABLE TO CONFIRM IF THE INFECTION WAS CAUSED BY OUR DEVICE. (B)(6).

    Description of Event or Problem · 1

    IN (B)(6), PATIENT CLAIMS WHILE USING OUR PRODUCT, HE NOTICED BURNING AND STOPPED USING. HE SAYS HE WAS PRESCRIBED 10 DAYS ANTIBIOTICS AND DOCTORS FOUND A KIDNEY STONE. PATIENT FURTHER DESCRIBES HE WENT TO THE HOSPITAL DUE TO THE INFECTION AND SPENT MOST OF THE HOLIDAYS THERE ((B)(6)). HE SAYS THAT INFECTION WENT TO KIDNEYS, ALSO A KIDNEY STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132894 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 D32001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization