BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 9225927 · Received October 23, 2019

    Report

    Report Number
    3001949129-2019-00006
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    May 16, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR'S NOTES MENTIONING HOSPITALIZATION WERE RECEIVED. THERE IS NO CONFIRMED HISTORY OF INFECTION RELATED TO OUR PRODUCT. WE ARE UNABLE TO CONFIRM IF THE INFECTION WAS CAUSED BY OUR DEVICE. PATIENT ALSO MENTIONED WEARING PADS WITH THE DEVICE.

    Description of Event or Problem · 1

    PATIENT CALLED IN ON (B)(6) 2019 TO ASK QUESTIONS ABOUT THE PRODUCT, AND SAYING HE IS HAVING SOME LEAKAGE. NURSE WENT OVER SOME TROUBLESHOOTING WITH HIM AND EXPLAINED HOW THE DEVICE NEEDS TO BE POSITIONED. DURING A FOLLOW-UP CALL ON (B)(6) 2019, HE STATED THE PRODUCT IS WORKING GREAT; HE WILL CALL BACK IF HE HAS FURTHER QUESTIONS. PATIENT WAS CONTACTED FOR ANOTHER FOLLOW-UP CALL ON (B)(6) 2019. HE STATED HE WAS DOING FINE BUT HAD A QUESTION ON HOW TO POSITION THE DEVICE WHILE SLEEPING. HE ALSO MENTIONED HE HAD A UTI BEFORE. CUSTOMER SERVICE WAS ABLE TO DETERMINE HE WAS HOSPITALIZED FOR TREATMENT OF THE UTI, THEN WENT TO AN INFECTIONS DISEASE SPECIALIST. HE HAD ALSO MENTIONED WEARING PADS WHILE USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017552 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 E09802

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization