BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL

    MDR report key: 6983454 · Received October 27, 2017

    Report

    Report Number
    3004167969-2017-00002
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 22, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    17290110120525
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF ALMA INC. (IMPORTER) . ALMA LASERS HAS REQUESTED THE CUSTOMER TO SEND THE SUSPECTED DEVICE FOR EVALUATION AND HAS ALSO PROVIDED THEM THE UPS RETURN LABEL. DEVICE EVALUATION WILL BE PERFORMED ONCE THE DEVICE IS RETURNED TO ALMA LASERS. HOWEVER AN ASSESSMENT OF WORLDWIDE ADVERSE INCIDENTS FOR THE SUBSTANTIALLY SIMILAR DEVICES WAS PERFORMED TO DETERMINE WHETHER THE ALLEGED INJURY IS ATTRIBUTABLE TO THE DEVICE. NO OTHER SIMILAR INCIDENTS WERE NOTED AND THE COMPANY BELIEVES THIS IS A SINGULAR INCIDENT. IN ALL GOOD FAITH EFFORTS ALMA LASERS IS REPORTING THIS INCIDENT TO THE FDA. SHOULD ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, ALMA LASERS LTD WILL FILE A FOLLOW-UP REPORT WITHIN TIME LINES PUBLISHED BY THE FDA. BASED ON THE INJURY REPORT, TREATMENT PARAMETERS WERE EVALUATED AND DETERMINED TO BE WITHIN RECOMMENDED RANGE(UPPER LIMIT). HOWEVER IT WAS NOTED THAT THE PATIENT UNDERWENT 13 TREATMENTS WHICH IS EXCESSIVE COMPARED TO ALMA LASERS RECOMMENDATION OF 4 TO 6 TREATMENT SESSIONS. THIS EXCESSIVE NUMBER OF TREATMENTS MAY EXPLAIN THE ROOT CAUSE OF THIS ADVERSE REACTION. THOUGH THERE IS NO INFORMATION AVAILABLE ON HOW THE PROCEDURE WAS DONE BUT IT IS ALSO POSSIBLE THAT A SMALL SECTION WAS OVER TREATED LEADING TO EXCESSIVE ENERGY ACCUMULATION THAT COULD HAVE REACHED THE DEEPER SKIN LAYER. A LETTER TO THE FACILITY WILL BE SENT TO EMPHASIZE ON FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS. ON (B)(6) 2017 THE CLINICAL EXPERT CONTACTED BY ALMA LASERS DIAGNOSED THIS DENT AS POSSIBLE LIPOATROPHY BASED ON AVAILABLE PHOTOGRAPHS. THIS IS PERMANENT AND MAY REQUIRE DERMAL FILLER. ALMA LASERS ATTEMPTED MULTIPLE FOLLOW-UPS ON THE PATIENT'S CONDITION. AS PER THE FOLLOW-UP PERFORMED ON (B)(6) 2017, THE CUSTOMER REPORTED THAT THE PATIENT IS GETTING BETTER HOWEVER NO ADDITIONAL PHOTOGRAPHS WERE MADE AVAILABLE FOR AN EXPERT'S ASSESSMENT. IN LACK OF ADDITIONAL PHOTOS, EVEN WHEN THE PATIENT IS GETTING BETTER ALMA LASERS CANNOT DETERMINE IF THE INJURY IS PERMANENT OR NOT. THE PATIENT IS SCHEDULED TO RETURN TO THE CUSTOMER'S FACILITY NEXT WEEK. ALMA LASERS HAS REQUESTED ADDITIONAL PHOTOGRAPHS FOR THE PURPOSE OF FURTHER MEDICAL ASSESSMENT DURING THIS VISIT. IN ALL GOOD FAITH EFFORTS ALMA LASERS IS REPORTING THIS INCIDENT TO THE FDA. SHOULD ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, ALMA LASERS LTD WILL FILE A FOLLOW-UP REPORT WITHIN TIME LINES PUBLISHED BY THE FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON SKIN TYPE III PATIENT FOR SKIN RESURFACING PROCEDURE ON FACE. THE PATIENT ALLEGED THAT HER SKIN WAS DENTED ON THE LEFT SIDE OF HER FACE(LOWER CHEEK AREA) AFTER THE LAST TREATMENT. BASED ON THE FACILITY NOTES THE PATIENT UNDERWENT 13 TREATMENTS WITH THIS SUSPECTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763563 HARMONY XL POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD. 1064NM (ND:YAG) MODULE 17290110120525

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other