BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILENT GUARD BALL VALVE

    MDR report key: 21783 · Received May 15, 1995

    Report

    Report Number
    MW1005919
    Event Type
    Injury
    Date Received
    May 15, 1995
    Date of Event
    April 6, 1995
    Report Date
    April 28, 1995
    Manufacturer
    AMERICAN OMNI MEDICAL
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALL SEATED; UNABLE TO UNSEAT BALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILENT GUARD BALL VALVE BALL VALVE LWQ AMERICAN OMNI MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R