BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINENT ILEO POUCH CATHETER

    MDR report key: 611270 · Received July 15, 2004

    Report

    Report Number
    2183558-2004-00013
    Event Type
    Injury
    Date Received
    July 15, 2004
    Report Date
    June 15, 2004
    Manufacturer
    MENTOR CORP - MINNESOTA DIV
    Product Code
    KPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFO THE PT STATES THE TIP OF THE LAST TWO ILEO CATHETERS THEY HAVE RECEIVED AND USED HAVE BROKEN OFF IN THEIR INTERNAL POUCH. BOTH OCCURENCES REQUIRED SURGERY WITH GENERAL ANESTHESIA AND IV ANTIBIOTICS. THEY MAY REQUIRE ADDITIONAL SURGERY TO LOCATE/REMOVE THE SECOND TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINENT ILEO POUCH CATHETER ILEO CATHETER KPH MENTOR CORP - MINNESOTA DIV 30-7025 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R