BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYCON

    MDR report key: 618234 · Received June 13, 2005

    Report

    Report Number
    618234
    Event Type
    Injury
    Date Received
    June 13, 2005
    Date of Event
    May 18, 2005
    Report Date
    June 13, 2005
    Manufacturer
    VITAID LTD.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED AND DIAGNOSED WITH UTI, URINARY TRACT INFECTION. A VCUG, VOIDING CYSTOURETHROGRAM, ORDERED. A 6 FR FOLEY CATHETER WAS INSERTED BY RN'S WITH RETURN OF CLEAR URINE. CYSTOGRAFFIN INSTILLED IN RADIOLOGY. EXTRAVASATION INTO ABDOMEN WAS NOTED. THE PATIENT BECAME UNSTABLE, AND REQUIRED TRANSFER FOR SURGICAL REPAIR OF DEFECT. PER UROLOGIST THERE WAS A "PIN SIZED HOLE REPAIRED" CONSISTANT WITH SIZE OF NYLON STYLET IN THE FOLEY. STYLET NOTED TO EASILY COME THROUGH HOLES BELOW BALLOON IF BALLOON BENT AS IF TOUCHING BLADDER WALL. STYLET END SHARP TO TOUCH ON ANOTHER FOLEY, SAME PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYCON FOLEY CATHETER, SILICONE 2-WAY KOD VITAID LTD. 1210106 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization| O| R