BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 12761717 · Received November 7, 2021

    Report

    Report Number
    3001949129-2021-00004
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL NOTES CONFIRMING THE HOSPITALIZATION WERE NEVER RECEIVED. DOCTOR'S NOTES LISTING MEDICAL HISTORY WERE ALSO NOT RECEIVED. WILL UPDATE THE REPORT IF THEY ARE RECEIVED. MANUFACTURING BATCH RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES NOTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THREE PRODUCT RETAINS FROM THIS LOT WERE TESTED WITH WATER. NO DRAINAGE ISSUES OR BACK UP WAS NOTED. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. WE ARE UNABLE TO CONFIRM IF THE INFECTION WAS CAUSED BY OUR DEVICE AS PATIENT STATED HE WAS ALSO USING DIAPERS AND PADS WITH OUR DEVICE. 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 REPORTED HE HAS BEEN EXPERIENCING UTI'S WHILE USING MEN'S LIBERTY DURING THE DAY. HE STATED HE WEARS DIAPERS AND A PAD AT NIGHT. HE STATED HE JUST GOT OUT OF THE HOSPITAL FOR UTI AND IS CURRENTLY TAKING ANTIBIOTICS WHILE STILL USING MEN'S LIBERTY. NURSE ADVISED HE STOP USE OF MEN'S LIBERTY UNTIL HE IS CLEARED OF INFECTION AND GAVE TIPS FOR USING MEN'S LIBERTY AT NIGHT TO MANAGE INCONTINENCE. HE STATED HE HAS HEAVIER INCONTINENCE AT NIGHT AND WILL CONSIDER USING MEN'S LIBERTY AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660090 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 G10901

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization