BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOTONA SP DINAMIS

    MDR report key: 4152370 · Received July 25, 2014

    Report

    Report Number
    9613462-2014-00001
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 25, 2014
    Manufacturer
    FOTONA D.D.
    Product Code
    GEX
    PMA / PMN Number
    K101306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THE INCIDENT WAS NOT A RESULT OF THE DEVICE'S MALFUNCTION. THE LABELING OF THE DEVICE IS ALSO CORRECT. THE THERAPIST ADMITTED SHE DIDN'T MAKE A TEST SPOT TO CHECK THE SENSITIVITY OF PATIENT'S FACIAL SKIN. OUT OF NATURE, SEQUENCE AND SHAPE OF THE BURNS TWO POSSIBLE ERRORS OF THE USER COULD BE SUSPECTED (ASIDE OF THE OMITTANCE OF TEST SPOT): - MISMATCHING OF THE SPOTS, THE USE OF 4 MM SPOT WITH SETTINGS FOR 9 MM SPOT, RESULTING IN MUCH HIGHER FLUENCES, OR STACKING OF PULSES ON ONE PLACE, RESULTING IN BUILDING UP THE TEMPERATURES BEYOND THE THERAPEUTIC ONES. THE LABELING OF THE DEVICE (APPLICATION NOTES CODE 85873 CE ENG/07, PAGE 69) PROVIDE CLEAR INSTRUCTIONS TO TEST THE PATIENT'S REACTION TO LASER HAIR REMOVAL BY ADMINISTERING A FEW LASER SHOTS ON TARGET AREA AND OBSERVE THE SKIN REACTION. NEVERTHELESS, AN ADDITIONAL CAUTIONARY WARNING WILL BE ADDED TO FUTURE LABELING, REMINDING THE USER TO BE SPECIFICALLY CAUTIOUS WHEN TREATING THINNER SKIN AS IS ON THE FACE.

    Description of Event or Problem · 1

    NEW FOTONA LASER USER (THERAPIST (B)(6)) TREATED A PATIENT (OF FITZPATRICK SKIN TYPE III) WITH MD: YAG FOR FACIAL HAIR REMOVAL. THE THERAPIST SAW GREY AND WHITE SKIN REACTION AND STOPPED IMMEDIATELY, HOWEVER, PATIENT HAS BLISTERED IN CERTAIN AREA WHERE THE HAIR WAS MOST DENSE SOME OTHER AREAS WERE OK. PRIOR TO FACIAL TREATMENT THE SAME PATIENT WAS TREATED WITH THE SAME LASER IN BIKINI LINE AREA WITH MODERATE SETTINGS AND 9 MM SPOT AND THERE WERE NO PROBLEMS. FACIAL TREATMENT OF THE HAIR WAS DONE WITH 4 MM SPOT AND FOLLOWING PARAMETERS: 50J/CM2; 1.6MSEC; 1 HZ. THE THERAPIST DIDN'T PERFORMED THE TEST SPOT FIRST TO CHECK THE REACTION OF THE SKIN. AFTER THE INCIDENT COOLING OF THE PATIENT SKIN WAS EXECUTED, (B)(6)OINTMENT GEL WAS APPLIED TO THE BURNED SURFACE. IN CONTINUATION OF THE HEALING PROCESS PATIENT USED TOPICAL ANTIBIOTIC CREAM KEPT THE SKIN MOISTURE. IN ADDITION LED THERAPY FOR BETTER AND QUICKER HEALING WAS DAILY EXECUTED IN THE SAME CLINIC. PICTURES OF HEALING PHASES AFTER 5 AND 12 DAYS ARE SHOWING NORMAL HEALING OF THE BURNS WITH CRUSTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436712 FOTONA SP DINAMIS GEX POWERED LASER SURGICAL INSTRUMEN GEX FOTONA D.D. M021-4AF/3

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other