BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT XL

    MDR report key: 6945929 · Received October 12, 2017

    Report

    Report Number
    3004167969-2017-00001
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 14, 2017
    Manufacturer
    ALMA LASERS LTD
    Product Code
    IMI
    PMA / PMN Number
    K160075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION LETTER E2013012 ALMA LTD. (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ALMA, INC. (IMPORTER). . PLEASE NOTE THAT FOR SYSTEM DEVICE WITH SERIAL (B)(4), THE APPROXIMATE AGE OF DEVICE AS REQUIRED IN THE REPORT IS 13 MONTHS. THE DEVICE MANUFACTURE DATE FOR THIS SYSTEM AS REQUIRED IN THE REPORT IS 09/01/2017. THIS INFORMATION COULD NOT BE ENTERED IN THEIR RESPECTIVE FIELDS DUE TO SOFTWARE LIMITATION. ALMA LASERS INVESTIGATED THE REPORTED EVENT AND ATTEMPTED FOLLOW-UPS ON PATIENT'S CONDITION. IN THE RECENT FOLLOW UP, IT WAS REPORTED THAT PATIENT'S TINNITUS HAS WORSENED AND SHE IS EXPERIENCING INCREASED HEARING LOSS IN HER AFFECTED EAR. DEVICES (SYSTEM AND HANDPIECE) WERE EVALUATED BY ALMA LASERS INC. (IMPORTER). THEY WERE FOUND TO BE WITHIN MANUFACTURING SPECS AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. AT THIS POINT, ALMA LASERS CANNOT DETERMINE IF THE PATIENT'S HEARING HAS WORSENED DUE TO THE PROCEDURE OR HAS BEEN DECREASING SUCCESSIVELY EVERY YEAR DUE TO THE HISTORY OF PRE-EXISTING CONDITION. IN ALL GOOD FAITH EFFORTS ALMA LASERS IS REPORTING THIS INCIDENT TO THE FDA. ALSO, CHIEF SCIENTIST OFFICER AT ALMA LASERS LTD RESEARCHED THE HISTORY OF THE ULTRASOUND HANDPIECE BY REACHING OUT TO THE EXPERTS USING THIS DEVICE WORLDWIDE AND FOUND NO SIMILAR EVENTS I.E. WORSENING OF TINNITUS. THIS IS A SINGULAR INCIDENT, HOWEVER, ALMA LASERS WILL EVALUATE ANY FUTURE SIMILAR EVENTS FOR A MEANINGFUL TREND. IF A TREND EMERGES, ALMA LASERS WILL TAKE NECESSARY ACTION AT THAT TIME. SHOULD ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, ALMA LASERS LTD WILL FILE A FOLLOW-UP REPORT WITHIN TIME LINES PUBLISHED BY FDA.

    Description of Event or Problem · 0

    THE SUSPECTED DEVICE WAS USED AT THE FACILITY ON A STAFF MEMBER (HEREAFTER, DESIGNATED AS THE PATIENT FOR THIS EVENT). THIS DEVICE WAS USED ON HER ARMS WITH THE RF PROCEDURE AND AFTER THAT ULTRASOUND WAS USED. PATIENT ALLEGEDLY REPORTED THAT FOLLOWING THE PROCEDURE HER PRE-EXISTING TINNITUS WORSENED IN THE LEFT EAR. SHE STATED THAT RIGHT AFTER THE ULTRASOUND PROCEDURE, HER LEFT EAR HAD AN "UNDERWATER" SOUND AND HER TINNITUS "DOUBLED IN THE INTENSITY". THE INTENSITY HAS NOT DECREASED SINCE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724327 ACCENT XL ULTRASONIC DIATHERMY IMI ALMA LASERS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other