BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.R. BARD

    MDR report key: 21394 · Received February 9, 1995

    Report

    Report Number
    21394
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    July 16, 1994
    Report Date
    January 31, 1995
    Manufacturer
    BARD UROLOGICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON JULY 16, 1994, A 38 YEAR OLD FEMALE PATIENT WHO HAD A URETHRAL CATHETER PLACED AT ANOTHER INSTITUTION, WAS TRANSFERRED TO THIS HOSPITAL. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON IN THE FOLEY CATHETER WITHOUT SUCCESS. A UROLOGIST HAD TO ENTER TRANSVAGINALLY TO RUPTURE THE BALLOON TO ALLOW REMOVAL OF THE ENTIRE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R. BARD Implant BARD UROLOGICAL DEVICE KOD BARD UROLOGICAL DIVISION 16F/5CC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention 1 DEGREE CESAREAN SECTION