BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)

    MDR report key: 24848367 · Received April 11, 2026

    Report

    Report Number
    3004450661-2026-00008
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    17290110120907
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A BURN AND DEPIGMENTATION AT THE TREATMENT SITE FOLLOWING THE USE OF THE HARMONY XL PRO SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION WHICH DETERMINED THAT THE BURN WITH SUBSEQUENT HYPOPIGMENTATION HAD LIKELY OCCURRED DUE TO USER TECHNIQUE. THE INVESTIGATION ALSO INDICATED REPIGMENTATION MAY OCCUR OVER TIME, THEREFORE WE ARE REPORTING THIS IN GOOD FAITH. THE DEVICE WAS REQUESTED FOR INSPECTION BUT THE CUSTOMER HAS NOT RETURNED THE DEVICE FOR INSPECTION OR RESPONDED TO THE DEVICE RETURN FOLLOW UP ATTEMPTS COMPLETED BY ALMA LASERS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119568 HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY) POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD. 1 17290110120907

    Patients

    Seq Age Sex Outcome Treatment
    1