BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVLT PROCEDURE KIT

    MDR report key: 596499 · Received April 22, 2005

    Report

    Report Number
    MW1035295
    Event Type
    Injury
    Date Received
    April 22, 2005
    Date of Event
    April 12, 2005
    Report Date
    April 22, 2005
    Manufacturer
    DIOMED INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPARENT BREAKAGE OF INTRODUCER SHEATH DURING EVLT PROCEDURE. RETAINED SEGMENT WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVLT PROCEDURE KIT INTRODUCER SHEATH FOR ENDOVENOUS LASER TREATMENT GEX DIOMED INC. REF: EVLT/PK-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LASER