BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETHRAL CATHETER

    MDR report key: 16137 · Received September 15, 1994

    Report

    Report Number
    MW1003365
    Event Type
    Malfunction
    Date Received
    September 15, 1994
    Date of Event
    August 17, 1994
    Report Date
    August 18, 1994
    Manufacturer
    BARD UROLOGICAL DIV. C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO REMOVE FOLEY, NURSE WAS ONLY ABLE TO REMOVE 2.5 CC STERILE WATER. SHE WAS THEREFORE UNABLE TO DEFLATE THE BALLOON. FOLEY WAS CUT, BUT RPTR WAS STILL UNABLE TO DEFLATE. BULB DEFLATED BY UROLOGIST 8/19 BY INSERTING A SMALL NEEDLE WHICH DEFLATED BALLOON. (THIS REPORT IS SAME AS REPORT NUMBER 1003239).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETHRAL CATHETER URETHRAL CATHETER KOD BARD UROLOGICAL DIV. C.R. BARD, INC. 16V

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR