BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL

    MDR report key: 3842810 · Received May 7, 2014

    Report

    Report Number
    3842810
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    12 FR SILICONE URINARY CATHETER THAT WAS INSERTED FOR PROCEDURE WAS DIFFICULT TO REMOVE AFTER PROCEDURE. BALLOON WAS DEFLATED ALL THE WAY BUT THE CATHETER STILL COULD NOT BE REMOVED. MD WAS CALLED AND HE SUCCESSFULLY REMOVED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274796 LUBRI-SIL CATHETER, UROLOGICAL EZL C.R. BARD, INC. * NGXF2023

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR