BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY SYSTEM

    MDR report key: 23974831 · Received January 6, 2026

    Report

    Report Number
    3004450661-2026-00001
    Event Type
    Injury
    Date Received
    January 6, 2026
    Report Date
    January 6, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THEIR PATIENT EXPERIENCED POST INFLAMMATORY HYPER-PIGMENTATION AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE POST INFLAMMATORY HYPER-PIGMENTATION IS LIKELY PERMANENT. MULTIPLE ATTEMPTS WERE MADE BY ALMA LASERS INC. TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER WITH NO RESPONSE, THEREFORE WE ARE REPORTING THIS IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34767 ALMA HARMONY SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other