BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELOS PLUS

    MDR report key: 5219538 · Received November 12, 2015

    Report

    Report Number
    3004772125-2015-00004
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    September 26, 2015
    Report Date
    November 9, 2015
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    GEX
    PMA / PMN Number
    K113868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEWING THE AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE IS USER ERROR. THE PATIENT WAS TREATED WITH HIGH PARAMETERS FOR ITS SKIN TYPE AND TREATED AREA.

    Description of Event or Problem · 1

    ON (B)(6) SYNERON CANDELA QA BECAME AWARE OF INFORMATION THAT REASONABLY SUGGESTS THAT A PATIENT, WHO WAS TREATED WITH ELOS PLUS SYSTEM AND SR PLUS APPLICATOR FOR PIGMENTATION ON HER ARMS AND LEGS, AT THE (B)(6) SPA, MAY HAVE SUSTAINED A REPORTABLE ADVERSE EVENT ON THE TREATED AREA. THE PATIENT, (B)(6), CONTACTED (B)(6) BY EMAIL, STATING THAT ON (B)(6) SHE WAS TREATED BY DR. (B)(6) FOR SUN SPOTS ON HANDS AND LEGS. FOUR DAYS POST TREATMENT, SHE RETURNED TO THE SPA, WHERE SHE WAS TOLD THAT THE SKIN HAD INCURRED SECOND DEGREE BURNS. ON (B)(6) THE PATIENT WENT TO A BURN UNIT, WHERE THE DOCTOR CONFIRMED THAT THE SKIN IRREGULARITIES WERE SECOND DEGREE BURNS THAT MOST LIKELY WOULD RESULT IN PIGMENTARY CHANGES THAT MAY BE PERMANENT. ON (B)(6) THE PATIENT CONSULTED WITH A DERMATOLOGIST REGARDING THE PIGMENTARY CHANGES. ON (B)(6), SHE UNDERWENT A FRAXEL (VALEANT PHARMACEUTICALS INTERNATIONAL, INC.) CO2 LASER TREATMENT TO TREAT THE PIGMENTATION. THE PATIENT IS NOW INCLUDING THE COST OF THE FRAXEL TREATMENTS IN HER CLAIM. SHE WAS PREVIOUSLY REIMBURSED FOR THE COST OF HER INITIAL TREATMENT AT LOTUS HEALTH & WELLNESS SPA. PHOTOS TAKEN ON (B)(6) 2015 SHOW DISCOLORATION THAT IS REPORTABLE IN SEVERITY. DR. (B)(6) AT THE (B)(6) SPA REPORTED THAT (B)(6), A FEMALE PATIENT (SKIN TYPE III), WAS TREATED WITH ELOS PLUS AND THE SR PLUS APPLICATOR FOR PIGMENTATION, SUSTAINED BURN MARKS AND SKIN IRREGULARITIES ON THE TREATED AREA. ACCORDING TO THE SYNERON CLINICAL SPECIALIST, WHO WAS IN TOUCH WITH DR. VERMA, TEST SPOTS WERE NOT PERFORMED PRIOR TO TREATMENT. THE TREATMENT RF ENERGY PARAMETER USED WAS 18J/CM3, WHICH IS NOT IN ACCORDANCE WITH THE INSTRUCTIONS IN THE USER MANUAL. THE USER MANUAL INSTRUCTS TO TREAT WITH RF ENERGY OF 10-15 J/CM3 ON THIN SKIN (LIKE THE PATIENT'S) AND WITH ENERGY OF 5J/CM3 ON BONY AREAS. DR. (B)(6) REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SEQUELA UNTIL A FEW DAYS AFTER THE TREATMENT, WHEN THE TREATED AREA BECAME RED AND IRRITATED. AT THE FIRST FOLLOW-UP, THERE WERE NO EVIDENCE OF LIQUID-FILLED BLISTERS, BUT THE SKIN APPEARED RED AND RAISED/SWOLLEN, WHICH CAN OCCUR WITH OLDER/THINNER SKIN. IT ALSO WAS REPORTED THAT THE PATIENT VISITED THE BURN CENTER AT (B)(6) HOSPITAL, WHERE THE STAFF REMOVED THE BLISTERED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750282 ELOS PLUS ELOS PLUS GEX SYNERON MEDICAL LTD. FG70532US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention