BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH NELATON CH14

    MDR report key: 1574103 · Received January 11, 2010

    Report

    Report Number
    2183558-2010-00001
    Event Type
    Injury
    Date Received
    January 11, 2010
    Report Date
    December 14, 2009
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RETURNED FOR EVALUATION. EXAMINATION REVEALED A FULL CATHETER IN A SEALED POUCH. THE TIP WAS INTACT, AND THE COMPLAINT CANNOT BE CONFIRMED AS REPORTED. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER. BASED ON THIS INFORMATION, COLOPLAST CONCLUDES THAT THIS IS AN ISOLATED INCIDENT AND DOES NOT REPRESENT THE OVERALL QUALITY OF THE LOT.

    Description of Event or Problem · 1

    DATE OF EVENT: 2009.ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED THAT THE TIP OF A CATHETER WAS CUT OFF. THE PATIENT INSERTED THE CATHETER AND THERE WAS SOME BLEEDING. THE PATIENT WENT TO THE DOCTOR. THERE WAS NO INTERNAL INJURY, AND NO MEDICATIONS WERE PRESCRIBED. THE BLEEDING STOPPED RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH14 INTERMITTENT CATHETER EYB COLOPLAST MANUFACTURING US, LLC 5045301400 2058518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention