BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNA

    MDR report key: 496540 · Received November 12, 2003

    Report

    Report Number
    2950887-2003-01065
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    October 17, 2003
    Report Date
    October 17, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A TUNA PROCEDURE THE PT EXPERIENCED PAIN IN THE AREA OF THE GROUNDING PAD. UPON CHECKING THE AREA IT WAS NOTED THAT THE GROUNDING PAD WAS NOT SECURED TO THE PT'S BACK. A SECOND GROUNDING PAD WAS PLACED AND THE PROCEDURE COMPLETED. FOLLOWING THE PROCEDURE THE PT WS NOTED TO HAVE WHAT WAS DESCRIBED AS A MINOR, FIRST DEGREE BURN ABOUT THE SIZE OF A DIME IN THE AREA WHERE THE ORIGINAL GROUNDING PAD WAS PLACED. THE AREA WAS TREATED WITH NEOSPORIN AND BANDAGING. ON FOLLOW-UP EXAMINATION THE AREA WAS REPORTED TO BE HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA EEA GEI MEDTRONIC GASTROENTEROLOGY/UROLOGY 1900TU 3J009V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other