BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOVER ALL SILICONE FOLEY CATHETER

    MDR report key: 41701 · Received October 9, 1996

    Report

    Report Number
    9610849-1996-00004
    Event Type
    Injury
    Date Received
    October 9, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 9, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 22 FR. SILASTIC FOLEY WITH 5CC BALLOON OPENED TO OR FIELD. PLACED IN PT BY DOCTOR DURING A PROSTATECTOMY PROCEDURE. WHILE CLOSING PT IT WAS NOTED FOLEY CAME OUT. UPON REINFLATION, IT WAS NOTED THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE DEFLATED. NEW 22 FR. SILASTIC WITH 5CC BALLOON OPENED AND TESTED WITH LEAKS. DUE TO THE PRESENCE OF SUTURES IN THE SWOLLEN BLADDER NECK, IT WAS NOT POSSIBLE TO REINSERT THIS CATHETER THROUGH THE URETHRA AND THE BLADDER NECK. REOPENING OF THE ABDOMINAL WOUND WAS NECESSIATED FOR PLACEMENT OF THIS CATHETER. THE WOUND WAS RECLOSED, AND THERE HAVE BEEN NO FURTHER COMPLICATIONS REPORTED ON THIS PT. REPORTEDLY, THE DOCTOR STATED, "1ST FOLEY TESTED WITHOUT LEAKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER ALL SILICONE FOLEY CATHETER FOLEY CATHETER FCN SHERWOOD DAVIS AND GECK NA 898435

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention