BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 7421796 · Received April 11, 2018

    Report

    Report Number
    3004167969-2018-00001
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    November 15, 2017
    Report Date
    March 27, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K033946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER (E2013012) ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA INC. (IMPORTER). (SECTION H.3) ALMA LASERS INC. (IMPORTER) INSPECTED THE HANDPIECE ON ALMA LASERS LTD (MANUFACTURER) BEHALF AND FOUND IT TO BE WITHIN SPECIFICATIONS. ALMA LASERS FAILED TO DUPLICATE THE ORIGINAL ERROR. ALMA LASERS INC.(IMPORTER) BECAME AWARE OF THE ALLEGED REPORTED EVENT ON 11/15/2017 AND SENT ALL THE RELEVANT INFORMATION TO ALMA LASERS LTD (MANUFACTURER) ON 12/01/2017. ALMA LASERS INVESTIGATED THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED BY THE FACILITY, ALMA LASERS CHIEF SCIENTIST OFFICER DETERMINED THAT SKIN TEST AVOIDANCE AND EXCESSIVE FLUENCE WITH NON-COOLED MODULE ON (DARK) SKIN TYPE IV WAS THE LIKELY ROOT CAUSE FOR THE ALLEGED EVENT. THE INDEPENDENT PHYSICIAN CONTACTED BY ALMA LASERS DIAGNOSED THIS AS A FIRST DEGREE BURN AND THAT THE DAMAGE WAS REVERSIBLE. HEALING TIME WAS ESTIMATED TO BE FEW DAYS TO WEEKS AND USE OF MILD STEROID CREAM WAS RECOMMENDED. BASED ON THE MEDICAL ASSESSMENT, THIS EVENT WAS EVALUATED TO BE NON-REPORTABLE. ALMA LASERS SENT A LETTER TO THE FACILITY TO REITERATE THE IMPORTANCE OF THE RECOMMENDED PROTOCOL. OVER THE COURSE OF NEXT 5 MONTHS, MULTIPLE PATIENT FOLLOW-UPS WERE PERFORMED. ON FIRST FOLLOW-UP, THE FACILITY REPORTED THAT THE PATIENT IS USING LIGHTENING SERUM. ON SECOND FOLLOW-UP, THE FACILITY REPORTED THAT THE PATIENT WAS SENT 2% HYDROQUINONE FOR PIGMENTATION BUT THEY DON'T THINK THE PATIENT IS USING IT. PATIENT TOLD THEM THAT SHE ONLY USES NATURAL PRODUCTS. ON THIRD FOLLOW UP, THE FACILITY REPORTED THAT THE PATIENT STILL HAS DARK SPOTS. ON 03/27/2018, THE FACILITY SENT FOURTH FOLLOW UP PHOTOGRAPH. UPON EXAMINING THE PROGRESSION OF FOLLOW UP INFORMATION (CONSIDERED AS ADDITIONAL INFORMATION), ALMA LASERS CHIEF SCIENTIST OFFICER RE-ASSESSED THE REPORTABILITY. IT WAS NOTED THAT ALTHOUGH THE PATIENT POSSIBLY DENIED THE RECOMMENDED TREATMENT; ALMA LASERS SHOULD REPORT THIS EVENT TO THE FDA IN GOOD FAITH EFFORTS. SINCE THE LAST FOLLOW-UP INFORMATION WAS RECEIVED ON 03/27/2018, IT IS BEING CONSIDERED AS THE REPORT DATE FOR THIS FORM. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE; ALMA LASERS LTD. WILL FILE A FOLLOW-UP REPORT WITHIN TIME LINES PUBLISHED BY THE FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON THE PATIENT WITH SKIN TYPE IV ON LEFT POSTERIOR THIGH/BUTTOCKS AREA FOR LEG VEINS. THE FACILITY REPORTED DARKENING, DISCOLORATION AND SCABBING WITH IMPRINT OF HANDPIECE. THERE WAS NO BLISTERING NOTED. THE FACILITY ALSO MENTIONED THAT THE HANDPIECE WAS RUNNING A LITTLE HOTTER THAN BEFORE. AS PER THE FACILITY, PATIENT'S HEALTH STATUS AT THE TIME OF COMPLAINT WAS WELL AND THE FEELING OF SUNBURN SUBSIDED WITHIN 24 HOURS. THE FACILITY DOCTOR DIAGNOSED THE ALLEGED INJURY AS "CRUST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263579 HARMONY MEDICAL LASER GEX ALMA LASERS LTD 540 MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other