BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY CONSOLE WITH GREEN DIODE

    MDR report key: 21368091 · Received February 12, 2025

    Report

    Report Number
    3004450661-2025-00004
    Event Type
    Injury
    Date Received
    February 12, 2025
    Report Date
    February 12, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR PATIENT EXPERIENCED A BURN POST TATTOO REMOVAL TREATMENT WITH THE ALMA HARMONY SYSTEM, WHICH WAS ASSESSED BY ALMA LASERS INC. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER AS EXPECTED TO HEAL WITHIN 4-6 WEEKS. ALMA LASERS INC. FOLLOWED UP WITH THE CUSTOMER REGARDING THE HEALING PROGRESS OF THE PATIENT'S BURN AND THE CUSTOMER REPLIED ON (B)(6) 2025 THAT THEY HAD NO NEW INFORMATION AS THEY HAD NOT SEEN OR RECEIVED ANY COMMUNICATION FROM THE PATIENT SINCE THE DATE OF THEIR ORIGINAL REPORT TO ALMA LASERS INC. THE CUSTOMER COULD NOT CONFIRM THE HEALING STATUS OF THE INJURY, THEREFORE WE ARE FILING THIS REPORT IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965631 ALMA HARMONY CONSOLE WITH GREEN DIODE ALMA HARMONY CONSOLE WITH GREEN DIODE GEX ALMA LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other