BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 21721500 · Received March 28, 2025

    Report

    Report Number
    3001949129-2025-00003
    Event Type
    Injury
    Date Received
    March 28, 2025
    Report Date
    March 28, 2025
    Manufacturer
    ARGENTUM MEDICAL, LLC
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE 1ST (TO DATE) SAFETY COMPLAINT FOR THIS LOT WITH ANOTHER REPORTED AFTER FOR A DIFFERENT REASON. MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED, AND THERE WERE NO DISCREPANCIES NOTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. DOCTOR'S NOTES WERE NOT RECEIVED BUT A REVIEW OF THE PATIENT HISTORY NOTES PROVIDED DURING INITIAL ACCOUNT SETUP WAS CONDUCTED. PATIENT HISTORY NOTES SHOWED A HISTORY OF URINARY INCONTINENCE, PROSTATE CANCER, AND UTI. THE PATIENT'S MEDICAL HISTORY OF INCONTINENCE OR HIM PLACING HIS ANATOMY INTO THE ML TUBE COULD HAVE CONTRIBUTED TO THE INFECTION, BUT THE CAUSE OF THIS REPORT IS UNCLEAR. COMPLAINT WILL BE UPDATED IF MORE INFORMATION IS PROVIDED BY THE PATIENT OR DOCTOR'S NOTES CONFIRMING INFECTION ARE RECEIVED. THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. AS A SHOW OF AN ABUNDANCE OF CAUTION, THE COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 0

    PATIENT WAS CONTACTED FOR FOLLOW UP. PATIENT'S WIFE STATED HE GOT A UTI FROM STICKING THE TOP OF HIS PENIS INTO THE ML TUBE IN ORDER FOR IT TO STAY ON LONGER. PATIENT'S WIFE STATED HE WAS IN REHAB FOLLOWING THE HOSPITAL STAY FOR THE UTI. PRODUCT SPECIALIST ADVISED STOPPING USE OF ML UNTIL COMPLETELY HEALED AND NOT TO STICK HIS ANATOMY INTO THE ML TUBE. PATIENT'S WIFE PROVIDED ML LOT # K32613. PRODUCT SPECIALIST LATER REACHED OUT TO THE PATIENT TO GET THE NAME OF THE HOSPITAL TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL. PATIENT IS A LONG-TIME USER, AND THE PATIENT'S WIFE STATED SHE WILL HELP HIM APPLY FROM NOW ON TO MAKE SURE IT IS DONE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693430 MEN'S LIBERTY EXTERNAL CATHETER NOA ARGENTUM MEDICAL, LLC 23046 K32613 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization