BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 14700102 · Received June 15, 2022

    Report

    Report Number
    3001949129-2022-00003
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL AND/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 THE PATIENT HAD TO QUIT TAKING A MEDICATION FOR RECURRENT UTI/CYSTITIS DUE TO SERIOUS SIDE EFFECTS. PATIENT STATED HE HAS A HISTORY OF URINARY TRACT INFECTIONS. PATIENT WAS ALSO USING ABSORBENT PRODUCTS WITH MEN'S LIBERTY WHICH COULD CAUSE EXCESS MOISTURE AROUND THE ANATOMY. REPORT WILL BE UPDATED IF FURTHER NOTES ARE RECEIVED. 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 WAS CONTACTED FOR PRODUCT USE FOLLOW UP. HE STATED HE CURRENTLY HAS A UTI WHILE USING MEN'S LIBERTY AND IS HOSPITALIZED DUE TO THE INFECTION. PATIENT STATED HE HAS A HISTORY OF UTI, AND THIS IS THE THIRD UTI. PATIENT STATED HE WAS TREATED WITH CIPRO AND OTHER ANTIBIOTIC FOR AN UNRELATED ISSUE. BIODERM PRODUCT SPECIALIST WENT OVER THE APPLICATION STEPS AND PRODUCT USE INSTRUCTIONS. PATIENT STATED HE WAS USING ADULT DIAPERS WITH MEN'S LIBERTY. THE PRODUCT SPECIALIST EXPLAINED THE RECOMMENDED UNDERWEAR AND WHEN TO DRAIN AND EMPTY THE MEN'S LIBERTY URINE COLLECTION POUCH. PATIENT STATED HE WILL RESUME USE OF MEN'S LIBERTY WHEN HIS ANTIBIOTICS ARE COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806781 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 H10801 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization