BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DDV LIGATOR URETHRAL SOUND

    MDR report key: 17623 · Received November 14, 1994

    Report

    Report Number
    MW1004011
    Event Type
    Malfunction
    Date Received
    November 14, 1994
    Report Date
    November 1, 1994
    Manufacturer
    NORTH AMERICAN MEDICAL, INC.
    Product Code
    FBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE DOING DEEP VENOUS LIGATION DURING RADICAL PROSTATECTOMY, THE TIP OF THE LIGATOR BROKE CLEANLY OFF THE TIP OF THE SOUND. IT WAS FOUND IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DDV LIGATOR URETHRAL SOUND URETHRAL SOUND TO LIGATE DEEP VENOUS PLEXUS FBX NORTH AMERICAN MEDICAL, INC. 17207094

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other