BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 11822548 · Received May 13, 2021

    Report

    Report Number
    3001949129-2021-00003
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL NOTES CONFIRMING THE HOSPITALIZATION WERE NEVER RECEIVED. DOCTOR'S NOTES LISTING MEDICAL HISTORY WERE ALSO NOT RECEIVED. MANUFACTURING BATCH RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES NOTES. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THREE PRODUCT RETAINS FROM THIS LOT WERE TESTED WITH WATER. NO DRAINAGE ISSUES OR BACK 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'S WIFE STATED HE WAS ON MEDICATION HIS DOCTOR SAID COULD CAUSE UTI. THERE IS NO INDICATION THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR MALFUNCTIONED, AND THE CAUSE IS NOT ESTABLISHED.

    Description of Event or Problem · 1

    PATIENT WAS CONTACTED FOR A ONE-WEEK PRODUCT USE FOLLOW-UP. PATIENT'S WIFE SAID THE PRODUCT WAS WORKING FINE BUT LAST FRIDAY, THE PATIENT GOT A UTI AND WAS HOSPITALIZED. SHE STATED THEY ARE AT REHAB NOW. PATIENT'S WIFE SAID THEY ONLY USED ML AT NIGHT AND ARE OUT OF TOWN. PATIENT'S WIFE MENTIONED THE ML WOULD COME OFF BY MORNING. SHE STATED HE WAS DIAGNOSED WITH MORGANELLA MORGANII AND NEVER HAD A UTI BEFORE. PATIENT'S WIFE CALLED BACK IN ON (B)(6) 2021. SHE SAID HE WAS USING ML AGAIN. PATIENT'S WIFE SAID HE WAS PRESCRIBED OXYBUTYNIN AND UNDERSTANDS HIS DOCTOR SAID THIS CAN CAUSE UTI'S. PATIENT'S WIFE SAID THEY ONLY USE ML AT NIGHT, HE IS NOT INCONTINENT, AND THAT HE JUST GOES FREQUENTLY AT NIGHT. SHE STATED HE IS CURRENTLY NOT TAKING ANY ANTIBIOTICS AND IS CLEARED OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714895 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 G08101

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization