BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLMAN SURGITRON 4.0 DUAL RF S5

    MDR report key: 1698844 · Received May 21, 2010

    Report

    Report Number
    2428235-2010-00003
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 22, 2010
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K082834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS THE FIRST TIME THAT THIS PHYSICIAN TREATED A PATIENT FOR NON-ABLATIVE WRINKLE REDUCTION WITH ELLMAN'S SURGITRON GENERATOR. THE PHYSICIAN HAD PREVIOUSLY BEEN TREATED AND OBSERVED ONE CASE. THE PRODUCT LABELING INDICATES: "IT IS IMPORTANT TO HAVE THE PATIENT'S FEEDBACK ON THE TEMPERATURE OF THE TREATMENT. IF THE PATIENT FEELS THAT THE TEMPERATURE IS TOO HOT, TURN THE SETTING ON THE SURGITRON DUAL RF GENERATOR DOWN BY APPROXIMATELY 10%. THE TREATMENT SHOULD BE WARM TO THE PATIENT BUT WITHOUT A BURNING SENSATION. THE SKIN TEMPERATURE SHOULD BE APPROXIMATELY 42 CELSIUS DURING IDEAL TREATMENT. "AN ICE PACK CAN BE APPLIED TO THE SKIN FOR APPROXIMATELY 10-15 SECONDS TO RELIEVE AND COOL THE SKIN AFTER TREATING AN AREA FOR APPROXIMATELY 5 MINUTES. THE SKIN MAY REDDEN OR DARKEN SLIGHTLY DUE TO THE TREATMENT. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS NOT WEARING MAKE-UP AND HE DID NOT PROVIDE THE PATIENT WITH ANY PAIN MEDICATIONS. THE PHYSICIAN WAS NOT AWARE OF RECENT INJECTIONS WITH FILLERS IN THE TREATMENT AREA. THE PATIENT WAS INSTRUCTED TO LET THE PHYSICIAN KNOW IF THE TREATMENT BECAME UNCOMFORTABLE. THE PHYSICIAN APPLIED TREATMENT GEL TO THE PATIENT'S FACE PRIOR TO THE TREATMENT. THE PHYSICIAN USED A 10MM HANDPIECE DURING THE TREATMENT WITH THE GENERATOR POWER SET AT 27-30. DURING THE TREATMENT, TEMPERATURE DID BECOME ELEVATED TO THE POINT THAT THE PATIENT SQUIRMED AND ATTEMPTED TO PULL AWAY MULTIPLE TIMES BUT THE PHYSICIAN CONTINUED TREATING THE SAME AREA WITHOUT LOWERING THE POWER SETTINGS OR PAUSING THE TREATMENT. THE SKIN TEMPERATURE WAS MONITORED THROUGH THE TREATMENT AND THE HIGHEST TEMPERATURE OBSERVED WAS 44 CELSIUS. THE PHYSICIAN CHOSE NOT TO USE ICE PACKS TO COOL THE SKIN. ON AT LEAST TWO OCCASIONS, THE PATIENT PULLED AWAY WITH THE HANDPIECE ENERGIZED AND RECEIVED ELECTRIC SHOCKS WHEN THE HANDPIECE AND SKIN SEPARATED FROM EACH OTHER. TWO RED SPOTS WERE OBSERVED ON THE LEFT SIDE OF HER FACE AFTER SHE PULLED AWAY FROM THE HANDPIECE AND ONE RED SPOT WAS OBSERVED ON THE RIGHT SIDE OF HER FACE. ON (B) (6) 2010, APPROXIMATELY A MONTH AFTER THE PROCEDURE, ELLMAN WAS NOTIFIED THAT THE SEVERITY OF THE ADVERSE REACTIONS OF THIS CASE HAD EXCEEDED THE EXPECTED ADVERSE REACTIONS OF REDNESS THAT TYPICALLY CLEARS UP WITHIN A COUPLE OF DAYS. THE BLISTERS TOOK ABOUT A MONTH TO HEAL. THE TWO RESIDUAL SCARS ON THE LEFT SIDE OF HER FACE WERE EXCISED BY THE PHYSICIAN APPROXIMATELY A MONTH AFTER SURGERY. THE ONE ON THE RIGHT SIDE WAS LEFT AS IT WAS.

    Description of Event or Problem · 1

    A PATIENT WAS TREATED BY THE PHYSICIAN FOR NON-ABLATIVE WRINKLE TREATMENT. FOLLOWING THE TREATMENT, 3 RED SPOTS WERE OBSERVED (TWO ON HER LEFT JAW LINE AND ONE ON HER RIGHT JAW LINE). THE NEXT DAY, THESE RED SPOTS BLISTERED AND BEGAN TO WEEP AND, IN THE PHYSICIAN'S OPINION, APPEARED TO BE SECOND DEGREE BURNS. THE PHYSICIAN PRESCRIBED A PROPRIETARY TREATMENT LOTION TO KEEP THE BLISTER MOIST. AFTER THE BLISTERS HAD HEALED, THE PHYSICIAN CHOSE TO EXCISE TWO OF THE SPOTS TO MINIMIZE ANY SCARRING/INDENTATION. THE EXCISIONS WERE PERFORMED APPROXIMATELY FOUR WEEKS FOLLOWING THE NON-ABLATIVE WRINKLE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELLMAN SURGITRON 4.0 DUAL RF S5 GEI ELLMAN INTERNATIONAL, INC. IEC5-S30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention