BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF CATH NELATON CH12

    MDR report key: 1910040 · Received November 30, 2010

    Report

    Report Number
    3005945907-2010-00032
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(6).ACCORDING TO THE INFORMATION RECEIVED THE LABEL SHOWS CH12 BUT THE CATHETERS IN THE BOX ARE CH14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH NELATON CH12 INTERMITTENT CATHETER KOD COLOPLAST A/S 5045201020 2118996

    Patients

    Seq Age Sex Outcome Treatment
    1