BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 11822561 · Received May 13, 2021

    Report

    Report Number
    3001949129-2021-00002
    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
    WI, 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 NOTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THREE PRODUCT RETAINS FROM THIS LOT WERE TESTED WITH WATER. NO DRAINAGE ISSUES OR BACKUP 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 DEVICES AS PATIENT'S WIFE STATED THERE WASN'T ANY BACK UP OR ISSUES WITH PRODUCT PERFORMANCES. 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'S WIFE CALLED IN TO REPORT HE WAS HOSPITALIZED WITH A UTI. SHE STATED THE NURSE IN THE HOSPITAL STATED BACTERIA IN THE LEG BAG MIGHT BE BACKING UP. PATIENT'S WIFE SAID IT IS NOT OVERFILLING, SHE WASHES IT BETWEEN USES, THE PRODUCT IS WORKING VERY WELL WITH NO ISSUES. PATIENT'S WIFE MENTIONED HE USED BRIEF'S WITH MEN'S LIBERTY WHICH COULD CAUSE ISSUES IF THE TUBE BECOMES BLOCKED OR URINE STAYS NEAR THE ANATOMY FOR TOO LONG. DOCTOR'S AND HOSPITAL NOTES WERE REQUESTED MULTIPLE TIMES TO GET A CONFIRMATION OR PATIENT MEDICAL HISTORY BUT WERE NEVER RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715216 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 G05301

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization