BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CV EVOLUTIONS SAPHLITE

    MDR report key: 1237518 · Received November 10, 2008

    Report

    Report Number
    1044475-2008-00038
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Report Date
    October 16, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FSW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO AVAILABLE. DEVICE RETURNED FOR EVAL. REPORT OF EVAL AND INVESTIGATION NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT DESCRIPTION WAS REPORTED AS: LIGHT GOT HOT DURING A SAPHENOUS VEIN HARVEST. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CV EVOLUTIONS SAPHLITE SAPHLITE FSW TELEFLEX MEDICAL NA 541205

    Patients

    Seq Age Sex Outcome Treatment
    1