BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL PRO

    MDR report key: 20556652 · Received October 29, 2024

    Report

    Report Number
    3004167969-2024-00025
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120907
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BURN WITH POST INFLAMMATORY HYPERPIGMENTATION (PIH) AFTER HARMONY HR. THE PIH MAY NOT COMPLETELY RESOLVE. BACKGROUND MEDICATION BEING USED (HYDROCHLOROTHIAZIDE) MAY INCREASE PHOTOSENSITIVITY AND INCREASE RISK OF BURNS.

    Description of Event or Problem · 0

    IT WAS REPORTED ABOUT A BURN WITH POST INFLAMMATORY HYPERPIGMENTATION FOLLOWING THE HARMONY XL PRO HR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303429 HARMONY XL PRO HARMONY XL PRO GEX ALMA LASERS LTD 17290110120907

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other