BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH NEALTON CH12

    MDR report key: 2223640 · Received August 25, 2011

    Report

    Report Number
    2183558-2011-00022
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 28, 2011
    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 HAS NOT 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 OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER THAT WAS CUT OFF AT THE TOP. THE TIP WAS MISSING SO THERE WAS A SHARP EDGE EXPOSED AT THE TOP PART OF THE CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH NEALTON CH12 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5045201400 2531146

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR