BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 7807145 · Received August 22, 2018

    Report

    Report Number
    3004167969-2018-00007
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 18, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110121379
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). THIS WAS DIAGNOSED AS A CASE OF Q-SWITCH INDUCED CHRYSIASIS CAUSED DUE TO RESIDUAL INTRACELLULAR GOLD RECEIVED FOR RHEUMATOID ARTHRITIS. THEREFORE, DEVICE IS NOT REQUIRED TO BE TESTED. DURING INVESTIGATION, THE CUSTOMER NOTED THAT THE PATIENT DID NOT PROVIDE ANY GOLD THERAPY, RHEUMATOID ARTHRITIS AND ANY RELATED MEDICATION HISTORY ON THE TREATMENT DAY. IT IS DURING THE FOLLOW-UP WHEN PATIENT INDICATED THAT SHE DID GET GOLD SHOTS IN THE PAST. THERE IS NO CORRECTIVE OR PREVENTIVE ACTION AS IT IS WIDELY KNOWN THAT LASER TREATMENTS SHOULD BE AVOIDED ON PATIENTS WITH HISTORY OF GOLD THERAPY. THIS IS ALSO COVERED IN USER TRAINING AND OPERATOR'S MANUAL. THIS DISCOLORATION MAY BE PERMANENT AND MAY REQUIRE ADDITIONAL LASER INTERVENTION. THEREFORE, ALMA LASERS IS REPORTING THIS TO THE FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON PATIENT'S FOREHEAD. AS PER THE FACILITY, SIX PULSES WERE APPLIED TO THE FOREHEAD. PATIENT INDICATED PAIN AND PURPLE HUE DEVELOPED. TREATMENT WAS SUSPENDED AFTER THE REACTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646178 HARMONY XL MEDICAL LASER GEX ALMA LASERS LTD Q SWITCH 1064 17290110121379

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability