BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 55007 · Received December 5, 1996

    Report

    Report Number
    1483039-1996-00019
    Event Type
    Injury
    Date Received
    December 5, 1996
    Date of Event
    April 14, 1994
    Report Date
    December 4, 1996
    Manufacturer
    PLASCO, INC.
    Product Code
    FCN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES THAT WHILE USING URINARY DRAINAGE BAG, THE SYRINGE PORT SQUARE CORNER CAUGHT ON THE FRAME OF THE PLAINTIFF'S BED AS PT WAS STANDING UP, THUS CAUSING SEVERE BLEEDING. THIS REPORT IS BASED ON INFO OFFERED IN A CIVIL LAWSUIT, WHICH NAMES CO AS DEFENDANTS. CO CANNOT DETERMINE WHETHER PRODUCT INVOLVED IN THIS REPORT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY DRAINAGE BAG URINARY DRAINAGE BAG FCN PLASCO, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization