BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 14856110 · Received June 29, 2022

    Report

    Report Number
    3001949129-2022-00005
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. HOSPITAL AND/OR DOCTOR'S NOTES CONFIRMING THE UTI OR HOSPITALIZATION WERE REQUESTED AND NEVER RECEIVED. DOCTOR'S NOTES LISTING MEDICAL HISTORY DURING INITIAL PATIENT SET-UP WERE REVIEWED. PATIENT NOTES DATED (B)(6) 2021 LIST THAT THE PATIENT HAS A HISTORY OF URINARY RETENTION, LOWER URINARY TRACT SYMPTOMS, URETERAL CALCULOUS OBSTRUCTION, AND FEELING OF INCOMPLETE BLADDER EMPTYING. REPORT WILL BE UPDATED IF FURTHER NOTES ARE RECEIVED. INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION. PER THE PATIENT'S WIFE, HIS DOCTOR CLEARED HIM OF INFECTION, AND THEY ARE STILL USING THE DEVICE. 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 WIFE REPORTED THE PATIENT HAS HAD TWO UTIS SINCE HE STARTED TO USE MEN'S LIBERTY EXTERNAL CATHETER IN (B)(6) 2021. PATIENT'S WIFE STATED HE WAS HOSPITALIZED FOR BOTH INFECTIONS AND IS IN A REHAB CENTER NOW. PATIENT'S WIFE STATED HE HAS BEEN CLEARED OF THE INFECTION BY HIS DOCTOR, IS STILL TAKING ANTIBIOTICS, AND IS STILL USING MEN'S LIBERTY. PRODUCT SPECIALIST WENT OVER THE APPLICATION STEPS AND EXPLAINED PROPER POSITIONING OF THE DEVICE TO ALLOW URINE TO FLOW AWAY FROM THE ANATOMY WITH GRAVITY. PATIENT OR PATIENT'S WIFE DID NOT REPORT THIS TO BIODERM PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153426 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 G31901 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization