BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIVEX

    MDR report key: 597486 · Received April 27, 2005

    Report

    Report Number
    1643264-2005-00017
    Event Type
    Death
    Date Received
    April 27, 2005
    Report Date
    April 25, 2005
    Manufacturer
    SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION
    Product Code
    DWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTED THROUGH THE YAHOO SMITH & NEPHEW MESSAGE BOARD THAT "THERE WAS A DEATH DUE TO BLOOD CLOT WHICH WAS REPORTED BY VNUS. ACCORDING TO THE REPORT SUBMITTED BY VNUS, TRIVEX WAS ALSO PERFORMED ON THE SAME PATIENT AND COULD NOT DETERMINE WHICH PROCEDURE MAY HAVE CAUSED THE CLOT." WE REVIEWED THE VNUS MDR (2953189-2005-00001) AND CAN FIND NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIVEX * DWQ SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death