BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL EXODUS CATHETER

    MDR report key: 1891667 · Received October 26, 2010

    Report

    Report Number
    1891667
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE CATHETER HAD BEEN SUTURED IN PLACE BUT WAS INADVERTENTLY REMOVED BY THE PATIENT WHEN BELTING HIS PANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL EXODUS CATHETER BILIARY CATHETER FGE NAVILYST MEDICAL 10005 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR