BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY

    MDR report key: 23544047 · Received November 13, 2025

    Report

    Report Number
    3004450661-2025-00022
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    07290110123369
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLLOWING USE OF THE ALMA HARMONY SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED BURNS AND BLISTERING AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE RESULTING SKIN DISCOLORATION SHOULD RESOLVE WITH APPROPRIATE CARE, HOWEVER, RECOVERY MAY TAKE SEVERAL MONTHS. THEREFORE, THIS INCIDENT IS BEING REPORTED IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165468 ALMA HARMONY POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD. 1 07290110123369

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other