BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH FEMALE CH14

    MDR report key: 1962990 · Received January 18, 2011

    Report

    Report Number
    2183558-2011-00005
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 20, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REPORTED AS BEING AVAILABLE BUT HAS NOT YET BEEN RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. DEVICE NOT YET RECEIVED BY MANUFACTURER

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, THE END USER FOUND A CATHETER WITH THE TIP CUT OFF. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH FEMALE CH14 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5046301400 5716360

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR