BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF CATH LONG PACKGED CURVED 14FR

    MDR report key: 2371290 · Received May 10, 2010

    Report

    Report Number
    2183558-2010-00011
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 13, 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 IN WHICH THE EYELETS AND TIP ARE TOO SHARP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF CATH LONG PACKGED CURVED 14FR INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5022101400 2301362

    Patients

    Seq Age Sex Outcome Treatment
    1