BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 108678 · Received July 29, 1997

    Report

    Report Number
    MW1011784
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    April 30, 1997
    Report Date
    July 29, 1997
    Manufacturer
    UNK
    Product Code
    DXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A NORWOOD PROCEDURE TO CORRECT TH VENTRICULAR DEFECT. THE ESOPHAGUS WAS BURNED AND IS NOW TOTALLY DESTROYED. THE PT WILL REQUIRE COMPLETE REPLACEMENT OF THE ESOPHAGUS WHEN THE PT. BECOMES 3 OR 4 YRS OLD. DR INFORMED RPTR THAT FIVE OTHER INFANTS EXPERIENCED THE SAME PROBLEM AROUND THIS EVENT DATE TIME PERIOD. RPTR IS CONCERNED ABOUT A LOT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ECHO-CARDIOGRAPH ELECTRODE DXK UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Life Threatening| R