BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY

    MDR report key: 8313196 · Received February 6, 2019

    Report

    Report Number
    3001949129-2018-00001
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    October 17, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REQUESTED TO HIS PROVIDER WHO STATED THAT DUE TO HIS HISTORY OF URINARY RETENTION, HE IS AT A HIGHER RISK FOR INFECTION. MEDICAL CHARTS FROM PROVIDER'S OFFICE CONFIRMS UTI INFECTION. PATIENT INFORMED THAT URINE WAS RETESTED AND IT CAME OUT CLEAR. NO FURTHER ISSUES REPORTED. PATIENT IS RESUMING DAILY ACTIVITIES. THERE IS NO CONFIRMED REPORTED HISTORY OF UTI RELATED TO OUR PRODUCT. WE ARE UNABLE TO CONFIRM IF THE UTI WAS CAUSED BY OUR DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE PATIENT, HE EXPERIENCED UTI TYPE SYMPTOMS AND WAS HOSPITALIZED FOR 6 DAYS WITH A CONFIRMED UTI HE BELIEVES WAS CAUSE BY OUR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103530 MEN'S LIBERTY EXTERNAL CATHETER NOA BIODERM, INC. 23046 D19701

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization