BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY

    MDR report key: 23342418 · Received October 20, 2025

    Report

    Report Number
    3004450661-2025-00021
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    07290110123369
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A SIGNIFICANT BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. THE INVESTIGATION PERFORMED BY ALMA LASERS INC. DETERMINED THE INJURY TO BE A SECOND DEGREE BURN, THEREFORE WE ARE REPORTING THIS IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801231 ALMA HARMONY POWERED LASER SURGICAL INSTRUMENT, GEX ALMA LASERS LTD. 1 07290110123369

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other