BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEN

    MDR report key: 467314 · Received June 17, 2003

    Report

    Report Number
    MW1028747
    Event Type
    Injury
    Date Received
    June 17, 2003
    Date of Event
    March 2, 2003
    Report Date
    June 17, 2003
    Manufacturer
    MERLEN MANUFACTURING & DEVELOPMENT CO
    Product Code
    KPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONTINENT ILEOSTOMY CATHETER FOLDED UPON INSERTION INTO BCIR VALVE ON TWO SEPARATE OCCASIONS, WITH TWO NEW CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEN 30 FRENCH CURVED CATHETER KPH MERLEN MANUFACTURING & DEVELOPMENT CO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention