BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF CATH NELATON CH14

    MDR report key: 1976186 · Received February 1, 2011

    Report

    Report Number
    3005945907-2011-00004
    Event Type
    Injury
    Date Received
    February 1, 2011
    Report Date
    January 6, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    KOD
    PMA / PMN Number
    K100878
    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.

    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. FOLLOW UP 1: ONE USED SAMPLE WAS PROVIDED FOR EVALUATION. EXAMINATION OF THE RETURNED PRODUCT REVEALED THERE WAS NO PACKAGING AND NO LOT NUMBER PROVIDED. THE CATHETER ITSELF WAS CUT OFF AT THE INSERTION END LEAVING A SHARP TIP. THEREFORE THE COMPLAINT IS CONFIRMED AS REPORTED. SINCE NO LOT NUMBER WAS PROVIDED, THE COMPLAINT HISTORY COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED THE USER STATES THAT A CATHETER HAD A SHARP/SQUARE TIP. THE PATIENT IS QUADRIPLEGIC AND SAID ONE CATHETER TIP WAS SHARP "LIKE A SHARPENED PENCIL". MOM DID NOT LOOK AT TIP BEFORE INSERTING AND PATIENT STARTED TO BLEED. PATIENT WENT TO EMERGENCY ROOM AND SAW UROLOGIST. CATHETER CUT URETHRA WHEN INSERTED. PATIENT IS NOW HOME FROM THE HOSPITAL. PATIENT ON MEDICATIONS AND CATHING DUE TO INCONTINENCE FROM QUADRIPLEGIA.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED THE USER STATES THAT A CATHETER HAD A SHARP/SQUARE TIP. THE PATIENT IS QUADRIPLEGIC AND SAID ONE CATHETER TIP WAS SHARP "LIKE A SHARPEND PENCIL". MOM DID NOT LOOK AT TIP BEFORE INSERTING AND PATIENT STARTED TO BLEED. PATIENT WENT TO EMERGENCY ROOM AND SAW UROLOGIST. CATHETER CUT URETHRA WHEN INSERTED. PATIENT IS NOW HOME FROM THE HOSPITAL. PATIENT ON MEDICATIONS AND CATHING DUE TO INCONTINENCE FROM QUADRIPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH NELATON CH14 INTERMITTENT CATHETER KOD COLOPLAST A/S 5045301400

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention