BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH NELATON CH 14

    MDR report key: 2371257 · Received May 12, 2010

    Report

    Report Number
    2183558-2010-00015
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 19, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE 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 INFO BE RECEIVED, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, AN END USER REPORTED A CATHETER WITH A ROUGH TIP. A PT HAD CALLED AND HAD ISSUES WITH THE 414. THE PT DID NOT FEEL THAT THE CATHETER WAS NOT COMPLETED PROPERLY. THE END OF THE STRAIGHT TIP WAS JAGGED AND NOT ROUNDED OR SMOOTHED. PT FOUND A FEW IN HIS BOX. PT HAS BEEN USING FOR A LITTLE OVER ONE YEAR WITHOUT THIS ISSUE. ORDERING THROUGH URO MED. PT HAS NO DEFECTIVE PRODUCT TO SEND IN. LOT # 1598992 EXP 11/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH NELATON CH 14 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5045301400 1598992

    Patients

    Seq Age Sex Outcome Treatment
    1