BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 22737187 · Received August 7, 2025

    Report

    Report Number
    22737187
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 9, 2025
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    UDI-DI
    00195278388483
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AFTER THE CONCLUSION OF THE ASD [ATRIAL SEPTAL DEFECT] CLOSURE PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY, THE PATIENT DEVELOPED A CONTACT TEAR/BURN DUE TO THE ECHO PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218781 NA TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX GE VINGMED ULTRASOUND AS 9VT-D 00195278388483

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Other