BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 14691287 · Received June 14, 2022

    Report

    Report Number
    3004450661-2022-00013
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    February 19, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ALMA LASERS, LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH SKIN TYPE 6 EXPERIENCED MULTIPLE SMALL AREAS OF SKIN WHITENING FOLLOWING A CARBON TREATMENT. PER LABELING TREATMENT WITH CARBON IS NOT A CLEARED INDICATION FOR THE DEVICE. ALMA LASERS INC. IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659316 HARMONY XL POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention