BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 22301746 · Received June 20, 2025

    Report

    Report Number
    3003622638-2025-00001
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    February 8, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ARGENTUM MEDICAL, LLC
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT SUPPLIED THE UDI FROM HIS PRODUCT WHICH INCLUDES THE PRODUCT LOT # K32613. MANUFACTURING RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES NOTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. IT IS ALSO UNCLEAR WHETHER THE PATIENT HAS SPOKEN TO OUR MEDICAL PRODUCT SPECIALISTS FOR TROUBLESHOOTING ON THIS MATTER. IN THE REPORT, PATIENT STATED HE HAS BEEN USING ML FOR 3 YEARS, BUT WE ARE UNABLE TO RETRIEVE PATIENT NOTES IN OUR SYSTEM WITHOUT ANY IDENTIFYING INFORMATION. IT IS UNKNOWN WHAT COULD CAUSE THE PATIENT TO EXPERIENCE SORES AND BLISTERS IF HE SUCCESSFULLY USED THE PRODUCT FOR 3 YEARS AND HAD NO REACTION DURING A SKIN TEST. WITHOUT MORE INFORMATION, THIS COMPLAINT CANNOT BE INVESTIGATED FURTHER. THIS IS ALSO BEING REPORTED TO THE FDA BY ARGENTUM IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    FDA CONTACTED US THAT A PATIENT HAD SUBMITTED AN ADVERSE EVENT REPORT THROUGH THEIR MEDWATCH PROGRAM (FORM MW5170048). PATIENT DID NOT SUPPLY ANY PERSONAL INFORMATION TO CONTACT THEM. PATIENT STATED HE STARTED TO EXPERIENCE SORES AND BLISTERS ON THE TIP OF HIS ANATOMY WHERE MEN'S LIBERTY IS APPLIED. HE STATED HE DID NOT HAVE ANY ISSUES FOR 3 YEARS OF PRODUCT USE UNTIL HE STARTED TAKING THE MEDICATION SPIRONOLACTONE. PATIENT STATED HE TRIED A SKIN TEST OF MEN'S LIBERTY AT THE ADVICE OF HIS DERMATOLOGIST, AND THAT HE DID NOT HAVE ANY REACTION TO MEN'S LIBERTY DURING HIS SKIN TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670086 MEN'S LIBERTY EXTERNAL CATHETER NOA ARGENTUM MEDICAL, LLC 23046 K32613 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other