BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFORT URETHRAL SOUND 24 FR.

    MDR report key: 195703 · Received November 5, 1998

    Report

    Report Number
    1423507-1998-00327
    Event Type
    Malfunction
    Date Received
    November 5, 1998
    Date of Event
    October 13, 1998
    Report Date
    November 5, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    FBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FILIFORM HAS BROKEN OFF THE TIP OF THE SOUND, DURING A SUPRAPUBIC CYSTOTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFORT URETHRAL SOUND 24 FR. INSTRUMENT FBX ALLEGIANCE HEALTHCARE CORP. GU4050-024 DI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR