BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 7045880 · Received November 20, 2017

    Report

    Report Number
    3004167969-2017-00004
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 20, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120525
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). ALMA LASERS INVESTIGATED THE REPORTED ISSUE. ON 11/09/2017, MEDICAL EXPERT CONTACTED BY ALMA LASERS STATED PHOTOGRAPHS PROVIDED BY THE FACILITY ARE OF POOR RESOLUTION. EXPERT PRESUMES THAT PATIENT'S SEMI-PERMANENT TATTOO WAS COMPOSED OF FERROUS OXIDE AND TITANIUM OXIDE. LASER TREATMENT ON THIS AREA CAUSED THE OXIDATION AND BLACKNESS (DISCOLORATION). THE RECOMMENDED TREATMENT FOR SUCH AN ALLERGIC REACTION IS 6 TO 10 TREATMENTS WITH Q-SWITCH RUBY OR YAG. AS PER ALMA LASERS LTD. CHIEF SCIENTIST OFFICER, FACILITY REPORTED TREATMENT PARAMETERS WERE WITHIN RANGE. UPON ASSESSING THE GIVEN SCENARIO, IT APPEARS THAT PATIENT SUFFERED LASER INDUCED PERMANENT MAKEUP ALLERGIC SKIN REACTION. THIS IS A WELL KNOWN ADVERSE REACTION IN SUCH CASES AND THUS PERMANENT MAKEUP AREA SHOULD HAVE BEEN AVOIDED. ALMA LASERS PERFORMED A PATIENT FOLLOW UP ON 11/14/2017, FACILITY INFORMED THAT THERE HAS BEEN NO CHANGE IN THE DISCOLORATION ON PATIENT'S FOREHEAD. PATIENT SAW A PERMANENT MAKE UP CONSULTANT AND WAS ADVISED THAT IT NEEDS TO BE RECOLORED. PERMANENT MAKE UP IS CONSIDERED A TATTOO AND LASER USE ON SUCH AREA SHOULD BE PROCEEDED WITH CAUTION. CLINICIAN SHOULD HAVE USED BETTER JUDGEMENT IN TREATING THE PATIENT. BASED ON EXPERTS EVALUATION, AT THIS POINT, IT SEEMS USER'S (CLINICIAN) ERROR IN JUDGEMENT IS THE LIKELY CAUSE OF THIS ADVERSE EVENT. A LETTER WILL BE SENT TO THE CUSTOMER TO EMPHASIZE ON KNOWN ADVERSE REACTIONS WITH THESE TREATMENTS. SINCE THE DEVICE IS NOT THE SUSPECTED ROOT CAUSE OF THIS EVENT, IT WAS NOT EVALUATED. ALMA IS SUBMITTING THIS IN GOOD FAITH EFFORTS. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE ALMA LASERS LTD. WOULD SUBMIT SUPPLEMENTAL REPORT TO FDA WITHIN THE PUBLISHED TIME LINES FOR SUCH REPORTING.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON SKIN TYPE II PATIENT FOR RESURFACING PROCEDURE ON HER FOREHEAD. PATIENT HAS A HISTORY OF PERMANENT MAKEUP ON HER FOREHEAD. PERMANENT MAKEUP IS TAN IN COLOR TO COVER HYPOPIGMENTATION. ACCORDING TO THE FACILITY, FEW DAYS AFTER THE Q-SWITCH TREATMENT, PERMANENT MAKE UP TURNED BLUE. FACILITY NURSE DIAGNOSED THE CONDITION AS BLUE STREAKS ON PATIENT'S FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825530 HARMONY XL POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD Q SWITCH 1064 17290110120525

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other