BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH PLUS MALE CH16

    MDR report key: 1624112 · Received March 8, 2010

    Report

    Report Number
    2183558-2010-00006
    Event Type
    Injury
    Date Received
    March 8, 2010
    Report Date
    February 11, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED FOR EVALUATION ALONG WITH THE UNSEALED POUCH IT CAME IN. VISUAL INSPECTION AND EXAMINATION OF THE CATHETER REVEALED THAT THE CATHETER HAD BEEN PLACED TOO FAR DOWN IN THE POUCH SO THAT THE TIP WAS CUT OFF DURING THE PACKAGING/SEALING PROCESS. THIS WAS EVIDENCED BY A VOID THROUGH THE END OF THE POUCH MATCHING THE OUTLINE OF THE CUT-OFF END OF THE CATHETER. THEREFORE, THE COMPLAINT IS CONFIRMED AS REPORTED. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER. BASED ON THIS INFORMATION, QA CONCLUDES THAT THIS IS AN ISOLATED INCIDENT AND DOES NOT REPRESENT THE OVERALL QUALITY OF THE LOT.

    Description of Event or Problem · 1

    DATE OF EVENT: (B) (6) 2010. ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH A TIP CUT OFF/OPEN/BROKEN. THE BROKEN TIP OF THE CATHETER WAS INSERTED AND BLEEDING OCCURRED WHEN IT WAS REMOVED.

    Description of Event or Problem · 1

    (B) (6). (B) (6). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A CATHETER WITH A TIP CUT OFF/OPEN/BROKEN. THE BROKEN TIP OF THE CATHETER WAS INSERTED AND BLEEDING OCCURRED WHEN IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH PLUS MALE CH16 INTERMITTENT CATHETER EYB COLOPLAST MANUFACTURING US, LLC 5049401400 2119336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention