BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPRANO ICE

    MDR report key: 8279869 · Received January 25, 2019

    Report

    Report Number
    3004167969-2019-00005
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    October 2, 2018
    Report Date
    December 26, 2018
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    UDI-DI
    17290110120693
    PMA / PMN Number
    K140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FOUND IT TO BE PERFORMING WITHIN THE MANUFACTURER SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED BY THE ACCOUNT, ALMA LTD. CHIEF SCIENTIST OFFICER DETERMINED THAT GIVEN THE PATIENT SKIN TYPE AND MULTIPLE AREAS TREATED, CONDUCTING A SKIN TEST PRIOR TO THE TREATMENT COULD HAVE PREVENTED THIS UNTOWARD SKIN REACTION. ALMA APPROACHED AN INDEPENDENT MEDICAL EXPERT FOR A FORMAL MEDICAL ASSESSMENT. AS PER THE ASSESSMENT, THE INJURY WAS REVERSIBLE AND THEREFORE, THIS EVENT WAS DEEMED TO BE NON-REPORTABLE AT THE TIME. (B)(4) PERFORMED PATIENT FOLLOW-UPS TO INQUIRE ABOUT PATIENT'S CONDITION. ON 12/26/2018, THE FACILITY REPORTED THAT THE PATIENT SEEMS TO BE HEALING WELL BUT WOULD REQUIRE LASER RESURFACING TO CORRECT SCARRING IN AT LEAST ONE OF THE TREATED AREAS. ALMA INC. REQUESTED THE FACILITY TO PROVIDE PATIENT PHOTOGRAPHS FOR ASSESSMENT; AS OF TODAY NO PHOTOGRAPHS HAVE BEEN RECEIVED. IN THE ABSENCE OF VISUAL EVIDENCE, ALMA CANNOT VALIDATE THE PRESENCE OF SCARS. BASED ON INTERNAL COMPANY PROCEDURES, ALMA IS SUBMITTING THE REPORT TO THE FDA AT THIS TIME.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON PATIENT'S BACK OF LEGS (CALVES), ELBOWS, BUTTOCKS AND HIPS (OUTER) FOR HAIR REMOVAL. AS PER THE FACILITY, PATIENT WITH SKIN TYPE V/VI SUSTAINED BLISTERS AND BURNS ON ALL AREAS. THE FACILITY PROVIDED CARE FOR WOUNDS BY CLEANING AND HYDRATING. PATIENT WAS ALSO PROVIDED ALOE/AQUAPHOR. THESE INJURIES WERE DIAGNOSED AS 1ST AND PARTIAL 2ND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71709 SOPRANO ICE MEDICAL LASER GEX ALMA LASERS LTD 810 17290110120693

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability