BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 5847018 · Received August 4, 2016

    Report

    Report Number
    3004167969-2016-00002
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 8, 2016
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). ALMA LASERS INVESTIGATED THE REPORTED EVENT AND CONTACTED THE USER FACILITY TO OBTAIN PHOTOS PERTINENT TO CLINICAL DIAGNOSIS BY AN EXPERT. THE PATIENT (STAFF IN THE FACILITY) REFUSED TO SHARE HER PHOTOS. DESPITE REASONABLE ATTEMPTS BY PHONE, NO PHOTOS WERE PROVIDED. IN ABSENCE OF PHOTOS IT WAS IMPOSSIBLE TO HAVE A MEDICAL ASSESSMENT OF THE INJURY. THEREFORE ALMA LASERS RELIES ON THE USER FACILITY PHYSICIAN FOR THE FOLLOW UP CONDITION OF THE PATIENT. A FOLLOW UP WAS PERFORMED ON (B)(4) 2016 AND THE PHYSICIAN NOTED THAT FACIAL SWELLING HAS DECREASED TO BILATERAL JAWLINES AND SLIGHTLY IN LOWER EYELIDS AS WELL. HOWEVER SMALL VASCULAR SPOTS ARE NOTED ON BOTH CHEEKS AND A SLIGHTLY RAISED AREA ABOVE THE ZYGOMATIC PROMINENCE. AS AN OVERALL PICTURE THE PHYSICIAN FEELS THAT THE PATIENT IS NOT HEALING THAT WELL. IN ALL GOOD FAITH EFFORTS ALMA LASERS IS REPORTING THE INCIDENT. THE TREATMENT SETTINGS ARE BEING EVALUATED. MULTIPLE ATTEMPTS WERE MADE TO REQUEST THE DEVICE BACK FOR INSPECTION. SO FAR WE HAVE NOT RECEIVED THE DEVICE. ONCE WE ARE ABLE TO DETERMINE THE CAUSE OR SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED/OBTAINED ON THIS INCIDENT ALMA LASERS LTD WILL FILE A FOLLOW-UP REPORT(S) WITHIN TIME LINES PUBLISHED BY FDA

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED SWELLING ON FACE AND EYELIDS AFTER THE PROCEDURE WITH SUSPECTED DEVICE. THE PATIENT FELT HER FACE WAS HOT AND RED. THE PATIENT ALSO REPORTED A PURPLE DARK CIRCLE ON CHEEK. PATIENT DENIES SUN EXPOSURE POST TREATMENT. THE PATIENT IS A STAFF MEMBER OF THE USER FACILITY AND IS PERFORMING PROCEDURES USING THE SAME HANDPIECE WITHOUT ANY ADVERSE RESPONSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498135 HARMONY MEDICAL LASER GEX ALMA LASERS LTD Q SWITCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other