BEUDAMED
    FDA Adverse Event Summary report: N

    VALLEYLAB

    MDR report key: 3940362 · Received July 11, 2014

    Report

    Report Number
    3940362
    Date Received
    July 11, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    JOS
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD AN ATRIAL ABLATION PROCEDURE FOLLOWED BY PERMANENT PACEMAKER INSERTION. AT THE END OF THE PROCEDURE THE TWO RETURN ELECTRODE GROUNDING PADS WERE REMOVED FROM THE BACK ABOVE THE WAIST ARE WITH SKIN DRY AND INTACT. THE NEXT DAY, THE PATIENT WAS GETTING DRESSED AND "FELT SOMETHING ON ITS BACK. THE NURSE, NURSE PRACTITIONER AND MD WAS NOTIFIED IN WHICH THERE WERE AN OPEN LESION AND CLOSED BLISTER. IT WAS TREATED WITH SILVADINE OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407927 VALLEYLAB ELECTRODE JOS COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR COVIDIEN VALLEYLAB NON-REM POLYHESIVE PATIENT RETU| ELECTROSURGICAL GENERATOR.| RETURN ELECTRODE, CARTO 3 MAPPING-BIOSENSE WEBSTER| OTHER| STOCKERT 70 ABLATOR, AND VALLEYLAB FORCE 2