BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH FEMALE CH12

    MDR report key: 2371291 · Received April 27, 2010

    Report

    Report Number
    2183558-2010-00013
    Event Type
    Malfunction
    Date Received
    April 27, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 29, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, A CATHETER HAD MISSING EYELETS. THE CUSTOMER REPORTED THAT SHE FOUND 3 SEALED PACKAGES WITHOUT ANY CATHETERS AND FOUND 1 CATHETER THAT DIDN'T HAVE ANY HOLES IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH FEMALE CH12 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5046201002 2048249

    Patients

    Seq Age Sex Outcome Treatment
    1