BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH NELATON CH12

    MDR report key: 2369497 · Received May 17, 2010

    Report

    Report Number
    2183558-2010-00016
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 22, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Adverse Event
    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 ADD'L INFO BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. NO FILES ATTACHED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, AN END USER REPORTED A CATHETER WITH A TIP CUT OFF/OPEN/BROKEN. A LONG TIME USER INADVERTENTLY INSERTED A CUT OFF TIP OF A CATHETER CAUSING INTERNAL BLEEDING AND REQUIRING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH12 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5045201400 2214088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention