BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 3796617 · Received April 23, 2014

    Report

    Report Number
    2951571-2014-00003
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 9, 2014
    Report Date
    April 22, 2014
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD UNDERGONE ENDOVENOUS LASER TREATMENT FOR VENOUS INSUFFICIENCY BY PRIVATE PHYSICIAN ON (B)(6) 2013. AT THE TIME, THE PATIENT HAD COMPLAINED OF PAIN IN HER CALF FOLLOWING THE PROCEDURE, BUT ULTRASOUND DID NOT REVEAL ANY ISSUES, AND THE PATIENT WAS TREATED FOR POSSIBLE THROMBOPHLEBITIS. THE PATIENT HAD FIVE FOLLOW-UP VISITS WHICH DID NOT UNCOVER ANY PROBLEMS. ELEVEN MONTHS LATER, ON (B)(6) 2014, THE PATIENT WENT TO THE ER FOR A "POKING" PAIN IN HER LEG THAT HAD BECOME "UNBEARABLE". PATIENT HAD A PIECE OF FIBER OPTIC THAT WAS PROTRUDING THROUGH THE SKIN SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244792 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention