BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD POLYHESIVE II

    MDR report key: 1883514 · Received October 19, 2010

    Report

    Report Number
    1883514
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AF ATRIAL FIBRILLATION ABLATION. AT CONCLUSION OF CASE, GROUNDING PAD NOTED TO BE LIFTED AWAY FROM PATIENT. A BURN WAS SEEN UNDER THE PAD. THE PAD HAD NOT CRINKLED AND WHILE NOT AFFIXED, WAS STILL FLAT AGAINST THE PATIENT.THE CASE WAS REVIEWED BY A MULTI-DISCIPLINARY TEAM. THEY IDENTIFIED SEVERAL POTENTIAL CAUSES OF THE BURN, OF WHICH ONE WAS THAT THE PAD MAY HAVE BEEN DEFECTIVE. THE PAD WAS DISCARDED AFTER THE EVENT SO IT CANNOT BE EVALUATED.======================HEALTH PROFESSIONAL'S IMPRESSION======================HEAT NOT ADEQUATELY DISSIPATED AND BURN DEVELOPED. PATIENT IS SEDATED AND NOT ABLE TO TELL TEAM S/HE FELT A BURN. THE PAD IS COVERED BY DRAPING AND NOT ASSESSED DURING THE CASE. THE PATIENT CANNOT BE MOVED DURING THE PROCEDURE. MOVING THE PATIENT MAY CAUSE THE ARRHYTHMIA MAPPING TO BE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD POLYHESIVE II PATIENT RETURN ELECTRODE GEI COVIDIEN VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R