BEUDAMED
    FDA Adverse Event Death Summary report: N

    6.2/5.0 MHZ OMNI TEE TRANSDUCER

    MDR report key: 521502 · Received April 19, 2004

    Report

    Report Number
    3003723454-2004-00004
    Event Type
    Death
    Date Received
    April 19, 2004
    Date of Event
    May 6, 2002
    Report Date
    April 19, 2004
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUNCTURED ESOPHAGUS WAS REPORTED. PT LATER EXPIRED. THERE WAS NO ALLEGATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE DEATH. EVENT OCCURRED IN 2002. PHILIPS WAS FIRST INFORMED OF EVENT IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.2/5.0 MHZ OMNI TEE TRANSDUCER 21367A ITX PHILIPS ULTRASOUND 21367A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death