BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH FEMALE CH14

    MDR report key: 1598920 · Received February 13, 2010

    Report

    Report Number
    2183558-2010-00004
    Event Type
    Injury
    Date Received
    February 13, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 18, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DATE OF EVENT: (B) (6) 2010. ACCORDING TO THE INFORMATION RECEIVED, A CATHETER TIP BROKE OFF INSIDE THE CUSTOMER. THE CUSTOMER STATES THAT THE CATHETER WAS INSERTED EASILY. SHE DID SHE HER PHYSICIAN AND HE TOLD HER ONCE SHE URINATES IT WILL COME OUT. CUSTOMER ALSO SAYS SHE IS VERY SORE. STILL HAS NOT FOUND THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH FEMALE CH14 INTERMITTENT CATHETER EYB COLOPLAST MANUFACTURING US, LLC 5046301400 2121096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention