BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.2/5.0 MHZ OMNI TEE TRANSDUCER

    MDR report key: 507959 · Received January 20, 2004

    Report

    Report Number
    3003723454-2004-00001
    Event Type
    Injury
    Date Received
    January 20, 2004
    Date of Event
    September 1, 2002
    Report Date
    January 16, 2004
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ESOPHGEAL BURNS, DISCOLORATION REPORTED. EVENT OCCURRED IN SEPT. 2002. PHILIPS FIRST BECAME AWARE OF EVENT IN JAN. 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.2/5.0 MHZ OMNI TEE TRANSDUCER 21369A ITX PHILIPS ULTRASOUND 21369A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O