BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0/3.7 MHZ OMNI TEE TRANSDUCER

    MDR report key: 224231 · Received May 19, 1999

    Report

    Report Number
    1218950-1999-00042
    Event Type
    Injury
    Date Received
    May 19, 1999
    Date of Event
    April 21, 1999
    Report Date
    April 22, 1999
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING TEE PROBE INSERTION; THE PROBE WAS MET WITH RESISTANCE AND HE TRIED SEVERAL TIMES TO INSERT THE PROBE. THE PHYSICIAN WAS NOT ABLE TO INSERT THE PROBE FOR STUDY. AFTER THE EXAMINATION, THE PT COMPLAINED OF THROAT PAIN. A VISUAL EXAM REVEALED A VISIBLE TEAR IN THE PHARNYX. SURGERY WAS PERFORMED TO REPAIR THE PHARNYX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0/3.7 MHZ OMNI TEE TRANSDUCER ENDOSCOPIC PROBES ITX HEWLETT-PACKARD CO. 21364A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening