BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY CONSOLE WITH GREEN DIODE

    MDR report key: 24393518 · Received February 19, 2026

    Report

    Report Number
    3004450661-2026-00004
    Event Type
    Injury
    Date Received
    February 19, 2026
    Report Date
    February 19, 2026
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    07290110123369
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE BURN WILL LIKELY RESOLVE OVER TIME, BUT THE USER FACILITY HAS NOT RESPONDED TO MULTIPLE ATTEMPTS MADE BY ALMA LASERS INC. TO CONFIRM PATIENT HEALING. THEREFORE, WE ARE REPORTING THIS IN GOOD FAITH. ADDITIONALLY, ALMA LASERS INC. HAS MADE DUE DILIGENCE EFFORTS TO OBTAIN THE DEVICE FOR FURTHER EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335607 ALMA HARMONY CONSOLE WITH GREEN DIODE POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD. 1 07290110123369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other