BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 23259 · Received July 7, 1995

    Report

    Report Number
    MW1006436
    Event Type
    Injury
    Date Received
    July 7, 1995
    Date of Event
    June 16, 1995
    Report Date
    June 20, 1995
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE OF RPTR'S PTS WAS FOUND WITH HALF OF HIS INDWELLING FOLEY CATHETER IN HIS HAND. IT OBVIOUSLY HAD BROKEN OFF SOME HOW AND THE OTHER HALF WAS STILL IN PLACE IN THE BLADDER AND URETHRA. THA PT HAD TO BE SENT TO THE LOCAL HOSP, WHERE THE LOCAL SURGEON EXTRACTED THE REMAINING PORTION OF THE CATHETER FROM THE PENIS WITH UTERINE FORCEPS. RPTR'S STAFF HAVE NEVER SEEN ONE "BREAK" IN TWO LIKE THIS BEFORE. RPTR WOULD APPRECIATE SOME FEEDBACK FROM THE CO AS TO WHETHER THIS HAS EVER HAPPENED BEFORE. CERTAINLY, THIS RESULTED IN A HARMFUL SITUATION FOR THE PT, WHICH WAS VERY EXPENSIVE, AND RPTR WOULD LIKE TO AVOID HAPPENING AGAIN IF AT ALL POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER URINARY CATHETER KOD PROFESSIONAL MEDICAL PRODUCTS, INC. 507581

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention