BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 14281474 · Received May 4, 2022

    Report

    Report Number
    3001949129-2022-00002
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 3, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL OR DOCTOR'S NOTES CONFIRMING THE UTI OR HOSPITALIZATION WERE REQUESTED AND NEVER RECEIVED. DOCTOR'S NOTES LISTING MEDICAL HISTORY DURING PATIENT SET-UP WERE REVIEWED. PATIENT NOTES MENTION A HISTORY OF URINARY INCONTINENCE, PROSTATE ISSUES, URINARY RETENTION, AND BLADDER OUTLET OBSTRUCTION. REPORT WILL BE UPDATED IF FURTHER NOTES ARE RECEIVED. NO LOT NUMBER OF THE DEVICE WAS PROVIDED SO, MANUFACTURING RECORDS WERE NOT ABLE TO BE REVIEWED. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED, AND THE CAUSE IS NOT ESTABLISHED.

    Description of Event or Problem · 0

    PATIENT'S DAUGHTER CALLED IN ON (B)(6) 2022 STATING SHE THINKS PATIENT GOT A UTI FROM THE MEN'S LIBERTY STARTER KIT THAT WAS PURCHASED. SHE EXPLAINED PATIENT IS CURRENTLY IN THE HOSPITAL DUE TO UTI. SHE EXPLAINED THE MEN'S LIBERTY BAG AND LEG BAG WERE ON FOR TWO NIGHTS, AND THAT THIS POSSIBLY CAUSED THE INFECTION. PATIENT'S DAUGHTER THINKS THE POUCH WAS OVERFILLING AND BACKING UP. NURSE EXPLAINED HOW TO AVOID INFECTION WITH PROPER APPLICATION AND POSITIONING. NURSE SPOKE WITH THE PATIENT'S DAUGHTER AGAIN ON (B)(6) 2022. PATIENT'S DAUGHTER EXPLAINED HE IS OUT OF THE HOSPITAL, CLEARED OF INFECTION, AND WANTS TO START TO USE MEN'S LIBERTY AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789343 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization