BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LASE

    MDR report key: 4152439 · Received July 25, 2014

    Report

    Report Number
    2428235-2014-00003
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ELLMAN INTERNATIONAL
    Product Code
    GEX
    PMA / PMN Number
    K110502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED ER:YAG LASER RESURFACING ON THE FACE. THE PROCEDURE REPORTEDLY WENT WELL WITH NO COMPLICATIONS. AT THE ONE WEEKS FOLLOW-UP APPOINTMENT THE PT REPORTED HEARING A SQUEALING IN HER LEFT EAR THAT BEGAN AFTER THE PROCEDURE. THERE WAS NO SIGN OF INFECTION OR TRAUMA IN OR AROUND THE EAR. PT WAS SUBSEQUENTLY SEEN BY AN ENT: NO SIGNS OF DAMAGE WERE EVIDENT. THE PT REPORTS THAT THE RINGING IN EAR IS IMPROVING AND IS CURRENTLY BEING SEEN BY A SPECIALTY EAR CLINIC FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436711 TRI-LASE LASER GEX ELLMAN INTERNATIONAL SSTRI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other