BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALMA HARMONY

    MDR report key: 2771648 · Received October 1, 2012

    Report

    Report Number
    MW5027115
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    May 2, 2011
    Report Date
    October 1, 2012
    Manufacturer
    ALMA HARMONY
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2011 HAD ALMA HARMONY LASER DONE AND WENT BACK FOR A SECOND TREATMENT IN (B)(6) 2011. THEN (B)(6) 2011 HAD THE REVITALIGHT SKIN CARE TREATMENT WEEKLY FOR SIX WEEK. AFTER BOTH TREATMENTS, STARTED NOTICING HALO AROUND HER EYES. FEELS THAT EITHER HIGH SETTING WAS USED OR THE MACHINE ITSELF WENT TOO FAR INTO HER SUBCUTANEOUS TISSUE DURING HER TREATMENTS. HER SKIN HAS GOTTEN PROGRESSIVELY WORSENING. NO IMPROVEMENT TO HER FACE, FACE LOOKS MUCH OLDER THAN SHE IS. OVERALL ENDED UP WITH WORSENING RESULTS AFTER LASER TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALMA HARMONY LASER GEX ALMA HARMONY
    2 REVITALIGHT SKIN CARE NONE GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other