BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV1600R

    MDR report key: 1098285 · Received August 5, 2008

    Report

    Report Number
    2951571-2008-00001
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    April 30, 2008
    Report Date
    August 4, 2008
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED ENDOVENOUS TREATMENT FOR VENOUS INSUFFICIENCY. THREE WEEKS AFTER RECEIVING TREATMENT, PATIENT REPORTED THAT A PIECE OF FIBER WAS POKING OUT OF THE TREATMENT ENTRY SITE. PATIENT PULLED FIBER OUT AND WENT BACK IN FOR FOLLOWUP. TWO ADDITIONAL PIECES OF FIBER OPTIC WERE DETECTED AND SUCCESSFULLY REMOVED BY THE PHYSICIAN FROM THE PATIENT'S LEG WITHOUT FURTHER INCIDENT. NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL EV1600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention