BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL PRO SYSTEM

    MDR report key: 23658661 · Received November 26, 2025

    Report

    Report Number
    3004450661-2025-00024
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 25, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLLOWING USE OF THE HARMONY XL PRO SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED BURNS AND BLISTERING AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE BLISTERS SHOULD SELF RESOLVE, HOWEVER WE ARE REPORTING THIS INCIDENT IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812219 HARMONY XL PRO SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Other