BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 14950206 · Received July 7, 2022

    Report

    Report Number
    3001949129-2022-00007
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    UDI-DI
    00653599000168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR NONCONFORMANCES NOTED. A PRODUCT RETAIN FOR THIS LOT WAS TESTED WITH WATER AND DRAINED AS INTENDED. HOSPITAL AND/OR DOCTOR'S NOTES CONFIRMING THE UTI OR HOSPITALIZATION WERE REQUESTED AND NEVER RECEIVED. PATIENT'S WIFE DID NOT GIVE CONSENT TO RELEASE RECORDS. REPORT WILL BE UPDATED IF NOTES OR FURTHER INFORMATION IS RECEIVED. INCONTINENCE PATIENTS ARE AT A HIGHER RISK FOR INFECTION. PER PATIENT'S WIFE, HE IS HOME, DOING BETTER, AND WON'T BE USING THE PRODUCT ANYMORE. 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 HER HUSBAND WAS HOSPITALIZED WITH UTI WHILE USING MEN'S LIBERTY. SHE STATED THE WEIGHT OF THE BAG WAS PULLING ON HIM AND NOT DRAINING INTO THE BED BAG. SHE STATED THEY ONLY USED MEN'S LIBERTY 3 TIMES. PATIENT'S WIFE STATED THIS IS THE FIRST TIME HE HAS HAD A UTI. PRODUCT SPECIALIST FOLLOWED UP WITH THE PATIENT'S WIFE THE NEXT DAY. PATIENT'S WIFE STATED HE SLEEPS MOSTLY ON HIS BACK, HARDLY TURNS, AND WEARS BRIEFS. SHE ALSO MENTIONED FINDING THE ML BAG STUCK UNDER HIS LEG. PRODUCT SPECIALIST EXPLAINED PROPER POSITIONING, HOW THAT AFFECTS URINE FLOW AWAY FROM THE ANATOMY WITH GRAVITY, AND THAT AN OBSTRUCTION COULD CAUSE URINE TO BACK UP. PATIENT'S WIFE STATED HE WAS TREATED WITH CIPRO ANTIBIOTICS, BUT HIS CONDITION WORSENED. SHE STATED HE EXPERIENCED SHAKING, LOSING CONSCIOUSNESS, AND AN ALTERED MENTAL STATE. SHE STATED HE WAS THEN HOSPITALIZED TO RECEIVE IV ANTIBIOTICS. PATIENT'S WIFE CALLED BACK IN ON (B)(6) 2022 TO REPORT HE WAS HOME AND DOING BETTER, BUT SHE IS NOT USING THE PRODUCT ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2850958 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 H10401 00653599000168

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization