BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOVER ALL SILIOCNE FOLEY CATHETER

    MDR report key: 38698 · Received September 4, 1996

    Report

    Report Number
    38698
    Event Type
    Injury
    Date Received
    September 4, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 3, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    KOD
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 22 FR SILASTIC FOLEY WITH 5 CC BALLOON OPENED TO OR FIELD. PLACED IN PT BY DR. WHILE CLOSING PT IT WAS NOTED FOLEY CAME OUT. UPON REINFLATION, IT WAS NOTED THAT BALLOON HAS A SLOW LEAK OF STERILE FLUID, THEREFORE, DEFLATED. NEW 22 FR SILASTIC WITH 5CC BALLOON OPENED AND TESTED WITHOUT LEAKS. PT ABDOMEN RE-OPENED AND FOLEY PLACED BY DR. DR STATES "1ST FOLEY TESTED WITHOUT LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER ALL SILIOCNE FOLEY CATHETER FOLEY CATHETER KOD SHERWOOD MEDICAL CO. * 898435

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention
    2