BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTORDE PAD, SPLIT

    MDR report key: 1190866 · Received October 6, 2008

    Report

    Report Number
    1643264-2008-00017
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 5, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A VALLEY LAB SPLIT PAD WAS PLACED ON THE THIGH OF THE OPERATIVE SIDE OF THE PATIENT. AFTER THE CASE, WHEN PAD WAS REMOVED THERE WAS 1" ROUND BURN ON THE THIGH. IT WAS MENTIONED THAT THE PATIENT MAY HAVE BEEN MOVED INTO THE BEACH CHAIR POSITION AFTER THE PAD WAS PLACED ON THE THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTORDE PAD, SPLIT GROUND PAD ODR SMITH & NEPHEW INC., ENDOSCOPY DIV. 7209687

    Patients

    Seq Age Sex Outcome Treatment
    1