BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 8152571 · Received December 11, 2018

    Report

    Report Number
    3004167969-2018-00012
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120433
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). ALMA INC. (IMPORTER) HAS EVALUATED THE HANDPIECE AND FOUND THAT IT MEETS MANUFACTURER'S SPECIFICATIONS. THE SYSTEM WAS ALSO INSPECTED AND IT WAS FOUND THAT IT HAD A DAMAGED HANDPIECE CONNECTOR. THE DAMAGED HANDPIECE CONNECTOR IS NOT LIKELY TO CONTRIBUTE TO THE ADVERSE EVENT AS THE SYSTEM CANNOT BE OPERATED IN THIS CONDITION. IT APPEARS THAT THE DAMAGE TO THE HANDPIECE CONNECTOR MAY HAVE OCCURRED DURING THE TRANSIT BACK TO ALMA. PER THE FACILITY, PATIENT BURNS WERE DIAGNOSED AS SECOND AND THIRD DEGREE BURNS. AT THIS TIME NO NEW PHOTOGRAPHS OR INFORMATION IS AVAILABLE TO ASSESS THE PATIENT SKIN CONDITION. THEREFORE, ALMA LASERS IS SUBMITTING THE REPORT TO FDA IN GOOD FAITH EFFORTS. BASED ON THE INFORMATION AVAILABLE, ALMA LASERS LTD. CLINICAL DETERMINED THAT FAILURE TO PERFORM SKIN TEST AND THE NUMBER OF PULSES ADMINISTERED FOR THE PATIENT'S SKIN CONDITION WERE LIKELY EXCESSIVE CONTRIBUTING TOWARDS THIS UNTOWARD SKIN REACTION.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON PATIENT'S LEGS BILATERALLY FOR BENIGN PIGMENTED LESIONS. THE FACILITY PROVIDED THE PATIENT WITH BIAFINE TOPICAL EMULSION AND 800 MG IBUPROFEN AS POST-TREATMENT CARE. PER THE FACILITY, THE PATIENT WAS SEEING A WOUND CARE SPECIALIST AS AN OUT-PATIENT INITIALLY BUT WAS LATER ADMITTED AS AN IN-PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992983 HARMONY MEDICAL LASER GEX ALMA LASERS LTD 540 VL/PL 17290110120433

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization