BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNUS VAREX PHLEBECTOMY INSTRUMENT

    MDR report key: 698478 · Received April 3, 2006

    Report

    Report Number
    2953189-2006-00003
    Event Type
    Malfunction
    Date Received
    April 3, 2006
    Date of Event
    March 13, 2006
    Report Date
    April 3, 2006
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT VAREX PROCEDURE ON 03/13/2006. DURING THE PROCEDURE, THE HOOK TIP BROKE IN THE PT'S VEIN. AN X-RAY WAS TAKEN TO LOCATE THE BROKEN TIP, AND THEN THE PHYSICAN REMOVED THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNUS VAREX PHLEBECTOMY INSTRUMENT FORCEP, MOSQUITO DQO VNUS MEDICAL TECHNOLOGIES, INC. VPH-R1R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention