BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 7870367 · Received September 12, 2018

    Report

    Report Number
    3004167969-2018-00009
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    February 8, 2018
    Report Date
    August 18, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120327
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). SECTION H3: ALMA INC. (IMPORTER) EVALUATED THE DEVICE AND FOUND THAT ENERGY OUTPUT WAS BELOW THE SPECIFICATIONS. AS PER ALMA LTD. CLINICAL, THIS FINDING IS NOT LIKELY TO CONTRIBUTE TO THE ADVERSE EVENT. BASED ON THE INITIAL PHOTOS AND INFORMATION PROVIDED BY THE FACILITY, ALMA LTD. CLINICAL CONCLUDED THAT GIVEN THE PATIENT'S DARK SKIN, THE COMBINATION OF EXCESSIVE FLUENCE AND SUBOPTIMAL COOLING ON THE SKIN BEFORE AND AFTER THE TREATMENT IS THE MOST LIKELY ROOT CAUSE FOR THIS UNTOWARD SKIN REACTION. THE INDEPENDENT MEDICAL EXPERT CONTACTED BY ALMA LTD FOUND THE INJURY TO BE REVERSIBLE FIRST-DEGREE BURNS. DUE TO NON-PERMANENT NATURE OF THE INJURY, THE EVENT WAS DEEMED NON-REPORTABLE AT THAT TIME. (B)(4). MADE MULTIPLE FOLLOW UP ATTEMPTS FOR PATIENT'S CONDITION AND THE FACILITY NOTED A POSITIVE RESPONSE. HOWEVER, ON 08/18/2018, (B)(4). RECEIVED PATIENT FOLLOW UP PHOTOS FROM THE FACILITY. THESE WERE FORWARDED TO ALMA LTD. FOR RE-ASSESSMENT. UPON REVIEW OF THE PHOTOS, ALMA LTD CLINICAL CONCLUDED THAT PATIENT STILL HAS HYPOPIGMENTATION AREAS AND PER COMPANY REPORTABILITY CRITERIA THIS SHOULD BE REPORTED TO THE FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON PATIENT'S THIGHS BILATERALLY FOR LEG VEINS. THE FACILITY DIAGNOSED THE INJURY AS A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708508 HARMONY XL MEDICAL LASER GEX ALMA LASERS LTD DYE VL 17290110120327

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability