BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEN'S LIBERTY ACUTE

    MDR report key: 8717024 · Received June 20, 2019

    Report

    Report Number
    3001949129-2019-00004
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED FROM THE REPORTER SUCH AS PART NUMBER, LOT NUMBER, HOW THE PRODUCT WAS USED, EXTENT OF THE REPORTED INJURY, HOW/IF THE PATIENT WAS TREATED, ETC., BUT NOTHING WAS PROVIDED TO US FOR FURTHER INVESTIGATION. WILL UPDATE REPORT IF MORE INFORMATION IS ACQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT A PATIENT DEVELOPED A DTI (DEEP TISSUE INJURY) ON THE HEAD AND SHAFT OF THE PENIS AFTER UTILIZATION OF THE MEN'S LIBERTY ACUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510868 MEN'S LIBERTY ACUTE EXTERNAL CATHETER NOA BIODERM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1