BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLMAN SURGITRON FFPF EMC

    MDR report key: 1719304 · Received June 10, 2010

    Report

    Report Number
    2428235-2010-00004
    Event Type
    Injury
    Date Received
    June 10, 2010
    Report Date
    May 7, 2010
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K972072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS INITIALLY REPORTED TO A SALES REPRESENTATIVE AT A CONVENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE DOCTOR TO GAIN ADDITIONAL INFORMATION, HOWEVER, SHE HAS NOT RESPONDED TO PHONE OR EMAIL MESSAGES. HER ASSISTANT DID SCHEDULE A TIME FOR A PHONE CONVERSATION TO TAKE PLACE, HOWEVER, THE PHYSICIAN FAILED TO PICK UP THE CALL. WHEN THE DOCTOR REPORTED THE INCIDENT TO OUR REPRESENTATIVE, THE PHYSICIAN WAS TOLD THAT ONLY FINE TEFLON COATED NEEDLE ELECTRODES AT A LOW POWER SETTING SHOULD BE USED FOR TREATING SMALL VEINS AND TELANGIECTASIAS AS INDICATED IN OUR IFU. THE PHYSICIAN DID NOT REMEMBER THE EXACT ELECTRODE MODEL THAT HAD BEEN USED. THE MANUFACTURER'S RECORDS SHOW THAT THIS ACCOUNT HAD NOT PURCHASED THE RECOMMENDED ELECTRODE FOR THIS PROCEDURE PRIOR TO REPORTING THE INCIDENT. THE GENERATOR AND ELECTRODE HAVE NOT BEEN RETURNED FOR OUR INVESTIGATION. BASED UPON THE AVAILABLE INFORMATION, IT HAS BEEN CONCLUDED THAT THE ADVERSE REACTION WAS A RESULT OF THE FAILURE TO FOLLOW THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A SPIDER VEIN USING THE SURGITRON EMC GENERATOR, THE PHYSICIAN HAD DIFFICULTY CONTROLLING THE BLEEDING. THE TREATMENT IN QUESTION OCCURRED OVER A YEAR AGO. IT WAS REPORTED THAT THE PROCEDURE CAUSED SWELLING, BRUISING AND ULTIMATELY SCARRING. THE PHYSICIAN COULD NOT REMEMBER THE EXACT ELECTRODE THAT WAS USED, ONLY THAT IT WAS A STRAIGHT WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELLMAN SURGITRON FFPF EMC GEI ELLMAN INT'L INC. EMC110A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention