BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL TRUMPET VALVE

    MDR report key: 533644 · Received July 9, 2004

    Report

    Report Number
    533644
    Event Type
    Injury
    Date Received
    July 9, 2004
    Date of Event
    May 4, 2004
    Report Date
    June 14, 2004
    Manufacturer
    CARDINAL HEALTH, CANADA, INC.
    Product Code
    FEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUCTION WOULD NOT RELEASE. HAD CONTINUOUS SUCTION FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TRUMPET VALVE * FEH CARDINAL HEALTH, CANADA, INC. ASU1201 Y3N1784

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention