BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPRANO XL

    MDR report key: 6018266 · Received October 11, 2016

    Report

    Report Number
    3004167969-2016-00003
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    February 14, 2015
    Report Date
    September 12, 2016
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K112031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PERTINENT INFORMATION RELATED TO THE EVENT, INCLUDING BUT NOT LIMITED TO, PATIENT'S AGE, GENDER, MEDICAL HISTORY, RELEVANT LAB RESULTS, TREATMENT PARAMETERS, PRE AND POST TREATMENT PHOTOS. THE USER FACILITY SHARED THE PATIENT'S AGE, GENDER, MEDICAL HISTORY AND TREATMENT PARAMETERS USED WITH ALMA LASERS. HOWEVER THE USER FACILITY IS NOT WILLING TO SHARE ANY PHOTOS OR ANY OTHER ADDITIONAL INFORMATION. IN ABSENCE OF PHOTOS IT WAS IMPOSSIBLE FOR ALMA LASERS TO CONDUCT MEDICAL ASSESSMENT OF THE INJURY. THEREFORE ALMA LASERS RELIES ON THE USER FACILITY'S PHYSICIAN FOR THE CLINICAL DIAGNOSIS OF THE PATIENT. THE PHYSICIAN DIAGNOSED IT AS A THIRD DEGREE BURN AND STATED THAT THE PATIENT REQUIRED SKIN GRAFTS. AT THIS TIME THERE IS NO ADDITIONAL DATA AVAILABLE ON THE PATIENT OUTCOME. ALMA LASERS IS SUBMITTING THIS REPORT IN GOOD FAITH EFFORTS. THE TREATMENT PARAMETERS WERE EVALUATED BY THE CLINICAL EXPERT. TOTAL ENERGY DELIVERED (REPORTED AS 1KJ) IS EXCESSIVE FOR SMALL AREAS SUCH AS GLABELLA AS REPORTED IN THIS CASE AND THAT MAY EXPLAIN THE ROOT CAUSE OF THE ADVERSE EVENT. THE EVALUATION OF TREATMENT PARAMETERS USED FOR THIS EVENT THAT OCCURED IN (B)(6) 2015 DOES INDICATE MISUSE. HOWEVER, THE PHYSICIAN HAS CONTINUED TO USE THE SUBJECT DEVICE WITHOUT ANY OTHER ADVERSE EVENTS. THEREFORE THE DEVICE WAS NOT EVALUATED.

    Description of Event or Problem · 0

    AS INTRODUCED BY THE COMPLAINANT (USER FACILITY), THE PATIENT (SKIN TYPE II) REQUIRED SKIN GRAFTS FOR THIRD DEGREE BURNS FOLLOWING HAIR REDUCTION PROCEDURE. THE INCIDENT OCCURED IN (B)(6) 2015 HOWEVER IT WAS REPORTED TO ALMA LASERS ONLY IN SEPTEMBER, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669333 SOPRANO XL MEDICAL LASER GEX ALMA LASERS LTD DIODE 810

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention