BEUDAMED
    FDA Adverse Event Other Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 39146 · Received August 2, 1996

    Report

    Report Number
    1483039-1996-00018
    Event Type
    Other
    Date Received
    August 2, 1996
    Date of Event
    July 1, 1996
    Report Date
    July 31, 1996
    Manufacturer
    PLASCO INCORPORATED
    Product Code
    KNX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BAG DID NOT DRAIN PROPERLY AND URINE BACKED UP INTO THE PT'S BLADDER. PT DEVELOPED URINARY TRACT INFECTION AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY DRAINAGE BAG URINARY DRAINAGE BAG KNX PLASCO INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other