BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH NEALTON CH14

    MDR report key: 2371294 · Received May 6, 2010

    Report

    Report Number
    2183558-2010-00020
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 18, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED CATHETER CONFIRMED THE COMPLAINT AS REPORTED. ONE EYELET HAD BEEN STAMPED ON THE SURFACE OF THE CATHETER, BUT NO EYELETS HAD BEEN PUNCHED OUT ON THE CATHETER. QA REVIEWED THE COMPLAINT HISTORY AND NOTED THIS IS THE FIRST COMPLAINT OF THIS LOT NUMBER TO DATE. THEREFORE, QA BELIEVES THIS IS AN ISOLATED INCIDENT AND DOES NOT REPRESENT THE OVERALL QUALITY OF THE LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, AN END USER REPORTED A CATHETER WITH MISSING EYELETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NEALTON CH14 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5045301400 2109945

    Patients

    Seq Age Sex Outcome Treatment
    1