BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 2231437 · Received August 23, 2011

    Report

    Report Number
    1717344-2011-00723
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE INSTRUCTIONS FOR USE WARN THAT NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATION, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PAD WAS BEING USED DURING AN ABLATION PROCEDURE. THE PATIENT EXPERIENCED A THIRD DEGREE BURN AT THE PAD SITE. THE BURN WAS DISCOVERED SEVERAL DAYS AFTER SURGERY WHEN THE PATIENT WENT TO THE DOCTOR COMPLAINING OF PAIN ON HER BACK. TWO PADS WERE USED DURING THE PROCEDURE AND THE PATIENT WAS NOT MOVED. THE PADS WERE BEING USED WITH A J AND J ABLATION GENERATOR. THE PATIENT IS BEING TREATED FOR THE BURN, BUT NO FURTHER INFORMATION ON TREATMENT SPECIFICS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other