BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPERSIVE ELECTRODE (TIN/KATECHO)

    MDR report key: 1215651 · Received October 8, 2008

    Report

    Report Number
    1056436-2008-00051
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    August 21, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, AWAITING DEVICE RECORD REVIEW FROM OEM DISTRIBUTOR OF PADS.

    Description of Event or Problem · 1

    PT HAVING RF ABLATION OF TUMOR FOR PAIN CONTROL TO LEFT POSTERIOR HIP. DISPERSIVE PADS PLACED BILATERALLY ON POSTERIOR THIGHS, WITH PT LYING PRONE. WHEN THE PROCEDURE WAS ALMOST COMPLETE, STAFF NOTICED THAT THE LEFT DISPERSIVE PAD WAS VERY WARM AND THE PROCEDURE WAS STOPPED AND THE DISPERSIVE PAD REMOVED. A BURN WAS APPARENT AND PLASTIC SURGERY CONSULT WAS IMMEDIATELY OBTAINED. THE PT WAS DIAGNOSED WITH 2ND AND 3RD DEGREE BURNS TO HIS LEFT POSTERIOR THIGH IN THE SHAPE OF THE DISPERSIVE PAD. FOLLOW-UP APPOINTMENTS WERE MADE FOR THE PT TO RETURN FOR EVALUATION BY THE DOCTORS. USER FACILITY REPORTED ON GENERATOR 1500X, A021370, HOWEVER, THE PT RECEIVED A PAD BURN SO THIS REPORT CONCERNS THE DISPERSIVE PAD 700-102623, Y040805-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPERSIVE ELECTRODE (TIN/KATECHO) DISPERSIVE ELECTRODE ODR ANGIODYNAMICS, INC. NA Y040805-5

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other