BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SELF-CATH CH14

    MDR report key: 2371304 · Received May 6, 2010

    Report

    Report Number
    2183558-2010-00019
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    February 1, 2009
    Report Date
    February 3, 2009
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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, A COMPLAINT WAS RECEIVED FROM (B)(6). SPOKE WITH DR. (B)(6) AND HE HAS HAD SEVERAL ISSUES WITH THE PRODUCT 450. HE HAS A FEW THAT HAVE NO EYELETS PUNCHED THROUGH (LOT 5725384).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG SELF-CATH CH14 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5022101400 5725384

    Patients

    Seq Age Sex Outcome Treatment
    1