BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPRANO XL

    MDR report key: 8242512 · Received January 11, 2019

    Report

    Report Number
    3004167969-2019-00002
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    September 27, 2018
    Report Date
    December 13, 2018
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    17290110120662
    PMA / PMN Number
    K083848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). SECTION H3: ALMA INC. (IMPORTER) HAS INSPECTED THE DEVICE AND IT APPEARS THAT UNIT MAY HAVE BEEN DROPPED OR HIT. THE OUTPUT WAS FOUND TO BE WITHIN THE MANUFACTURER'S SPECIFICATIONS BUT THE THERMOELECTRIC COUPLING (TEC) WAS NON-OPERATIONAL. ALMA LASERS MADE MULTIPLE ATTEMPTS TO REQUEST PATIENT PHOTOGRAPHS AND PERTINENT ADVERSE EVENT INFORMATION. THE FACILITY DID NOT PROVIDE THE ADVERSE EVENT DETAILS UNTIL THE DAY BEFORE THE REPORTABILITY 30-DAY DEADLINE. ALMA LASERS LTD. CLINICAL REVIEWED THE INFORMATION AND FOUND SOME OF THE PERTINENT INFORMATION TO BE LACKING. ALMA LASERS LTD. CLINICAL DETERMINED THAT VITAL INFORMATION ON PAST TREATMENT RECORDS NEED TO BE EXPLORED. IN THE ABSENCE OF VISUAL EVIDENCE AND PERTINENT CLINICAL INFORMATION, AT THIS TIME, NO ROOT CAUSE CAN BE ASSESSED. ALMA LASERS IS INVESTIGATING THIS ISSUE AND WILL SUBMIT SUPPLEMENTAL REPORTS WITHIN THE FDA PUBLISHED TIMELINES IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S LOWER LEGS (BELOW KNEES TO ANKLES) FOR UNWANTED HAIR. PATIENT BLISTERED ALL UP AND DOWN ON ANTERIOR SHINS THAT EVENING. PATIENT WAS SEEN BY THE FACILITY AGAIN AND HYPOPIGMENTATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34598 SOPRANO XL MEDICAL LASER GEX ALMA LASERS LTD. 810 17290110120662

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other