BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VL 45CM KIT (FIBER), PRODUCT CODE GEX

    MDR report key: 1277264 · Received December 17, 2008

    Report

    Report Number
    2134812-2008-00009
    Event Type
    Malfunction
    Date Received
    December 17, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 19, 2008
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K071216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR REMOVED THE BRIGHT TIP FIBER FROM THE PACKAGING AND NOTICED THAT HALF OF THE CERAMIC TIP FELL OFF. SHE OPENED A NEW PROCEDURE KIT TO USE A PROPER FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VL 45CM KIT (FIBER), PRODUCT CODE GEX VARI-LASE BRIGHT TIP FIBER GEX VASCULAR SOLUTIONS, INC. 7113 (7105) 542838

    Patients

    Seq Age Sex Outcome Treatment
    1