BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SELF-CATH PKGD CURVED CH14

    MDR report key: 2371253 · Received June 9, 2010

    Report

    Report Number
    2183558-2010-00021
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 14, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K100878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 ADD'L INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    BEST ESTIMATE IS (B)(6) 2010. ACCORDING TO THE INFO RECEIVED, A COMPLAINT WAS RECEIVED FOR MISSING EYELETS. SEVEN OR EIGHT OF THE PACKAGES DIDN'T HAVE ANY CATHETERS IN THEM. SOME DIDN'T HAVE A TIP FOR URINE TO COME OUT, THEY WERE JUST SOLID WITH NO HOLES. PT THREW CATHETERS OUT SO DOESN'T HAVE ANY TO RETURN AND DOESN'T HAVE LOT NUMBERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1