BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 5869929 · Received August 11, 2016

    Report

    Report Number
    3004167969-2013-00006
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    October 29, 2013
    Report Date
    November 5, 2013
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K072564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF 2013 MDR. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION. AN EXAMINATION OF THE HAND-PIECE BY THE DISTRIBUTOR CONCLUDED NO ISSUES WITH THE DEVICE. HOWEVER, ALMA LTD CONSIDERS THIS AS AN INCONCLUSIVE INVESTIGATION IN ABSENCE OF ALL THE RELEVANT INFORMATION TO INVESTIGATE THE LIKELIHOOD OF INCORRECT OPERATING TECHNIQUE, USE OF INCORRECT TREATMENT PARAMETERS OR SOME OTHER ASPECT OF DEVICE. ALMA LTD IS MAKING EFFORTS TO COLLECT ALL THE INFORMATION, TO FOLLOW-UP ON PATIENT'S MEDICAL CONDITION. SHOULD ANY ADDITIONAL INFORMATION BE OBTAINED OR RECEIVED, ALMA LTD. WILL FILE A SUPPLEMENTAL REPORT(S) WITH FDA WITHIN THE FDA PUBLISHED TIME-LINES FOR SUCH REPORTING.

    Description of Event or Problem · 1

    ALMA LTD WAS NOTIFIED OF THIS EVENT BY DISTRIBUTOR ON 11/05/2013 WITH INCOMPLETE DATA. EXACT INCIDENT DATE WAS ALSO UNKNOWN AS INITIAL REPORTER STATED "WEEK BEFORE THE DATE OF REPORT." ALMA LTD WAS NOT SUCCESSFUL IN GATHERING PERTINENT INFORMATION TO COMPLETE THE REPORT IN-SPITE OF GOOD FAITH EFFORTS. IT WAS REPORTED THAT TWO PATIENTS SUSTAINED BURNS ON LOWER BACK AFTER THE TATTOO REMOVAL PROCEDURE WAS PERFORMED USING THE SUSPECTED DEVICE. ALMA LTD IS SUBMITTING TWO MDRS FOR TWO DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521005 HARMONY MEDICAL LASER GEX ALMA LASERS LTD Q SWITCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other