BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVLT II KIT

    MDR report key: 629105 · Received August 23, 2005

    Report

    Report Number
    1225808-2005-00002
    Event Type
    Injury
    Date Received
    August 23, 2005
    Report Date
    August 2, 2005
    Manufacturer
    DIOMED, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER AN EVLT LASER PROCEDURE WAS COMPLETED, THE DOCTOR BEGAN TO REMOVE THE LASER FIBER, WHEN THE REMOVAL FROM THE VEIN WAS COMPLETE, THE DOCTOR REALIZED THAT A PIECE OF THE SHEATH REMAINED IN THE PT. THE PT WAS BROUGHT TO SURGERY AND THE PIECE REMOVED. IT APPEARS THAT THE FIBER WAS FIRED INSIDE OF THE SHEATH AND CONSEQUENTLY THE SHEATH WAS SEPARATED AT THE AREA WHERE THE LASER FIRED. THE PT IS FINE AND WILL REQUIRE NO FURTHER FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT II KIT LASER FIBER AND KIT GEX DIOMED, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention