BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 4100980 · Received September 19, 2014

    Report

    Report Number
    1717344-2014-00824
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    March 30, 2012
    Report Date
    August 28, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS NOT RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE RECEIVED 2ND AND 3RD DEGREE BURNS AS WELL AS NERVE DAMAGE FROM A GROUNDING PAD DURING A RIGHT KIDNEY ABLATION PROCEDURE ON FRIDAY(B)(6) 2012. THE BURN WAS NOT NOTED AT THE TIME OF THE SURGERY. THE PATIENT REPORTED THAT SHE WAS INITIALLY PLACED ON HER STOMACH WITH THE PAD PLACED ON HER RIGHT THIGH. SHE WAS THEN TURNED OVER AT THE REQUEST OF THE ANESTHESIOLOGIST. SHE IS UNAWARE OF ANYTHING AFTER THAT. THE NEXT EVENING (SATURDAY) FOLLOWING HER PROCEDURE, SHE HAD HEAT AND TISSUE SWELLING AT THE PAD SITE. ON SUNDAY SHE WENT TO URGENT CARE WITH A BLISTER. ON MONDAY, SHE WENT TO HER RADIOLOGIST'S OFFICE. SHE WAS INSTRUCTED TO TREAT THE AREA WITH SILVADENE OINTMENT AND NOT TO POP THE BLISTER. FOUR TO FIVE DAYS LATER, THE BLISTER BURST. SHE HAS SCARRING AND NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584330 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP E7506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BOSTON SCIENTIFIC RF3000 GENERATOR