BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF CATH PED CH08

    MDR report key: 1896928 · Received November 11, 2010

    Report

    Report Number
    3005945907-2010-00024
    Event Type
    Injury
    Date Received
    November 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZD
    PMA / PMN Number
    K100878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(6). ACCORDING TO THE INFORMATION RECEIVED, A CATHETER HAD A TIP CUT OFF/OPEN/BROKEN. PATIENT'S MOTHER FOUND A CATHETER THAT WAS CUT OFF AT THE TIP. HAD TRIED INSERTING IT AND FOUND BLOOD COMING OUT OF THE URETHRA. MOTHER SAYS SHE ATTEMPTED INSERTING IT A FEW TIMES BEFORE REALIZING THE CATHETER WAS CUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH PED CH08 INTERMITTENT CATHETER EZD COLOPLAST A/S 5044201400 2348293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention