BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX

    MDR report key: 124985 · Received October 3, 1997

    Report

    Report Number
    MW1012242
    Event Type
    Injury
    Date Received
    October 3, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 3, 1997
    Manufacturer
    CR BARD, INC. BARD UROLOGICAL DIV.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE EMERGENCY DEPT C/O LT FLANK PAIN ETC. URGENCY AND DYSURIA. A BARD BRAND 16 FRENCH FOLEY CATHETER WAS INSERTED AND ANCHORED WITH IT'S BALLOON INFLATION. AFTER TESTING WAS DONE, THE STAFF WERE UNABLE TO DEFLATE THE CATHETER BALLOON TO REMOVE THE FOLEY. A UROLOGIST WAS CONSULTED. HE WAS ABLE TO USE A SMALL GUAGE WIRE TO DEFLATE THE BALLOON. THE PTS ED. STAY WAS EXTENDED BY SEVERAL HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX 16F# FOLEY CATHETER KOD CR BARD, INC. BARD UROLOGICAL DIV. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention