BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPRANO XL

    MDR report key: 5837453 · Received August 1, 2016

    Report

    Report Number
    3004167969-2015-00002
    Event Type
    Injury
    Date Received
    August 1, 2016
    Date of Event
    November 5, 2014
    Report Date
    January 8, 2015
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K112031
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF A PREVIOUSLY SUBMITTED MDR IN 2015. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION. EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF ALMA LASERS INC. (IMPORTER) THE OPERATOR DID NOT DOCUMENT ANY SERIAL NUMBER AS A RESULT OF WHICH WE CANNOT DETERMINE WHICH DEVICE CONTRIBUTED TO THIS EVENT. THEY SEEM TO HAVE MULTIPLE SYSTEMS AND HAND PIECES OF THE SUSPECTED PRODUCT TYPE.ONE OF THE SYSTEM AND HANDPIECE WAS REQUESTED BACK FOR INVESTIGATION. THE DEVICE MET MANUFACTURING SPECS AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. A FIELD TECHNICIAN IS SCHEDULED TO INVESTIGATE THE OTHER SYSTEMS AND HAND PIECES IN THE WEEK OF FEB 23, 2015. AT THIS TIME THE ROOT CAUSE IS INDETERMINATE. THE ABSENCE OF SERIAL NUMBERS LED TO THE DELAY IN REPORTING AS WE DID NOT HAVE ADEQUATE INFORMATION TO DETERMINE WHICH DEVICE CONTRIBUTED TO THIS EVENT. THE CLINICAL PERSONNEL EVALUATED THE INCIDENT AND FOUND NO PROTOCOL DEVIATION. THERE WAS ANOTHER SIMILAR INCIDENT REPORTED ON THE SAME DATE IN SAME FACILITY USING THE SAME SUSPECTED PRODUCT TYPE AND THE PATIENT HEALED FINE. THE SAME CLINICAL OUTCOME WAS EXPECTED FOR THE PATIENT IN THIS REPORT AS WELL. HOWEVER FOLLOW UP PHOTOS FROM 02/11/2015 DO REVEAL RESIDUAL HYPERPIGMENTATION. IT MAY OR MAY NOT BE PERMANENT. IN GOOD FAITH EFFORTS ALMA LTD IS REPORTING THIS TO FDA. SHOULD ANY ADDITIONAL INFORMATION BE AVAILABLE ALMA LTD. WILL FILE FOLLOW UP REPORT(S) WITH FDA

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED ON SKIN TYPE IV FOR HAIR REDUCTION PROCEDURE ON RIGHT HIP AND WAIST. THIS WAS PATIENT'S SEVENTH PROCEDURE SESSION. THE PATIENT DID NOT REPORT BLISTERS UNTIL HE RETURNED FOR NEXT APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488448 SOPRANO XL MEDICAL LASER GEX ALMA LASERS LTD DIODE 810

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other