BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLY BAG

    MDR report key: 531916 · Received March 4, 2004

    Report

    Report Number
    2429473-2004-00023
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Report Date
    March 4, 2004
    Manufacturer
    RUSCH, INC.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BAG IS LEAKING AROUND AND DRAIN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELLY BAG UROLOGICAL KNX RUSCH, INC. NA 125308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN