BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 20745049 · Received November 21, 2024

    Report

    Report Number
    3001949129-2024-00001
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 SET UP WAS CONDUCTED. PATIENT HISTORY NOTES SHOWED REOCCURRING HISTORY OF URINARY INCONTINENCE BLADDER AND RETENTION ISSUES. THE PATIENT'S MEDICAL HISTORY OF INCONTINENCE COULD CONTRIBUTE TO AN INFECTION, AS INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION, BUT THE CAUSE IT IS UNCLEAR FROM THEIR REPORT. PRODUCT SPECIALIST FOLLOWED UP WITH PATIENT ON (B)(6) 2024, BUT PATIENT STATED HE DIDN'T HAVE TIME FOR ANY F/U QUESTIONS AND TO CALL BACK IN A FEW WEEKS. 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. COMPLAINT WILL BE UPDATED IF MORE INFORMATION IS PROVIDED BY THE PATIENT OR DOCTOR'S NOTES CONFIRMING INFECTION ARE RECEIVED.

    Description of Event or Problem · 0

    PRODUCT SPECIALIST REACHED OUT TO THE PATIENT REGARDING REORDERING AND WAS INFORMED THAT THE PATIENT IS NOT CURRENTLY USING ML. PATIENT STATED HE FELL IN THE BATHROOM WEARING ML AND WAS UNABLE TO GET OFF THE GROUND FOR 14 HOURS BEFORE GETTING HELP TO THE HOSPITAL. PATIENT STATED HE WASN'T AWARE HE HAD A UTI UNTIL BEING DIAGNOSED AT HOSPITAL. PATIENT STATED AT THE HOSPITAL SENT HIM HOME WITHOUT ANY ANTIBIOTICS, LEADING TO A RELAPSE. PATIENT STATED HE PREFERS TO WEAR ML OVER DEPENDS/ABSORBENT PADS BUT IS AFRAID TO WEAR ML AFTER SUFFERING FROM UTI. PRODUCT SPECIALIST REACHED OUT TO THE DOCTOR ON TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447602 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 K10707 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization