BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIREFULX URINARY DRAINAGE DEVICE

    MDR report key: 19037 · Received January 19, 1995

    Report

    Report Number
    MW1004789
    Event Type
    Malfunction
    Date Received
    January 19, 1995
    Date of Event
    January 10, 1995
    Report Date
    January 10, 1995
    Manufacturer
    PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS INDWELLING FOLEY CATHETER. CATHETER DRAINAGE BAGS LEAKING THREE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIREFULX URINARY DRAINAGE DEVICE ANTIREFLUX URINARY DRAINAGE DEVICE KNX PROFESSIONAL MEDICAL PRODUCTS, INC. 40020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other