BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 4187719 · Received October 14, 2014

    Report

    Report Number
    2951571-2014-00004
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    May 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD UNDERGONE ENDOVENOUS LASER TREATMENT FOR VENOUS INSUFFICIENCY IN (B)(6) 2014. THE PT LATER REPORTED PAIN IN THE RIGHT FLANK IN (B)(6) 2014. THE PT UNDERWENT SURGERY AND A 25CM SEGMENT OF FIBER OPTIC WAS RETRIEVED FROM THE FLANK WOUND. IT WAS REPORTED THAT THE PT HAS RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649989 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention