BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 11882 · Received March 4, 1994

    Report

    Report Number
    1483039-1994-00002
    Event Type
    Injury
    Date Received
    March 4, 1994
    Report Date
    February 10, 1994
    Manufacturer
    PLASCO
    Product Code
    FON
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TAKEN TO ER WHERE 2000 ML OF URINE WAS DRAINED FROM HER BLADDER.THE BAGS SEEM TO PLUG UP AFTER BEING USED FOR A SHORT TIME. URINE BEGINS TO DRAIN INTO THE BAG, BUT MUCH MORE URINE IS RETAINED IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A DRAINAGE BAG FON PLASCO N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention