BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH NELATON CH14

    MDR report key: 1379669 · Received March 9, 2009

    Report

    Report Number
    2183558-2009-00012
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 9, 2009
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FCM
    PMA / PMN Number
    K003873
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICE HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. 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. NO OTHER COMPLAINTS HAVE BEEN RECORDED TO DATE FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    AN END USER REPORTED THAT HE CURRENTLY USES 414 AND HAD ONE THAT HAD NO TIP FORMED ON IT. IT WAS REPORTEDLY VERY SHARP. THE END USER STATES HE DID NOT LOOK AT CATHETER BEFORE INSERTING IT, AND WHEN HE USED IT, IT WAS VERY PAINFUL. IT CAUSED BLEEDING AND THE END USER CALLED THE DOCTOR, WHO INDICATED THAT IF THE BLEEDING STOPPED, IT WAS LIKELY THAT NO SERIOUS DAMAGE OCCURRED. THE BLEEDING STOPPED, BUT THE END USER HAS AN APPOINTMENT WITH DOCTOR TOMORROW (WAS SCHEDULED BEFORE INCIDENT WITH CATHETER) AND WILL ASK IF ANY HARM WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH14 INTERMITTENT CATHETER FCM COLOPLAST MANUFACTURING US LLC 5045301400 1702598

    Patients

    Seq Age Sex Outcome Treatment
    1