BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 8537525 · Received April 22, 2019

    Report

    Report Number
    3001949129-2019-00002
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 22, 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 · 1

    DOCTOR'S NOTES RECEIVED. 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.

    Description of Event or Problem · 1

    PATIENT CONTACTED US ON 3/26/19 SAYING HE WAS TREATED FOR UTI WITH ANTIBIOTICS, WHILE USING OUR PRODUCT. HE HAD BLOOD IN URINE. DOCTOR'S NOTES DATED A FEW DAYS BEFORE ((B)(6) 2019) SHOW HE WAS TREATED FOR ACUTE CYSTITIS WITH HEMATURIA, CLOUDY URINE OR DYSURIA, ETIOLOGY UNCLEAR, AND RISK OF UTI VERSUS CHRONIC COLONIZATION OR CONTAMINATION OF SAMPLE WITH CATHETERIZATION. OTHER NOTES WERE RECEIVED FOR DOCTOR FOLLOW UP ON (B)(6) 2019. IT SAYS HE WAS HOSPITALIZED (B)(6) 2019 - (B)(6) 2019. IT WAS FOUND HE HAD AN (B)(6) UTI AND WAS TREATED WITH ANTIBIOTICS. PATIENT HAS A HISTORY OF HEMATURIA, PROSTATE CANCER, CHEMOTHERAPY, AND OTHER HEALTH ISSUES. HE WAS WEARING OUR DEVICE TO TREAT INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331235 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 E00501

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization