BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF-CATH TIEMAN TAPER-TIP CH08

    MDR report key: 1337526 · Received March 9, 2009

    Report

    Report Number
    2183558-2009-00011
    Event Type
    Injury
    Date Received
    March 9, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 9, 2009
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003873
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    A DISTRIBUTOR REPORTED ON BEHALF OF AN END USER WHO USED PRODUCT 608 & CATHETERIZES EVERY 4 HOURS. IN 2009 EVENING, THE PT'S MOTHER WAS CATHETERIZING HIM AND LOOKED AT THE CATHETER PRIOR TO USE AND THE TIP WAS PRESENT. SHE INSERTED THE CATHETER EASILY THE FIRST 6 INCHES AND THEN HER CHILD BEGAN TO CRY AND EXPRESSED THAT IT WAS PAINFUL. MOTHER TRIED MOVING THE CATHETER TO THE RIGHT BECAUSE SHE THOUGHT THAT SHE WAS JUST INSERTING IT WRONG, BUT THE PAIN PERSISTED; SO, SHE REMOVED THE CATHETER. UPON REMOVAL OF THE CATHETER FROM THE PENIS, THE TIP WAS MISSING. NO ACTION WERE TAKEN THAT NIGHT OR THE FOLLOWING DAY BECAUSE NO BLEEDING OCCURRED. THEN THE NEXT DAY, PUS WAS VISIBLE ON THE PENIS, SO THE PATIENT'S FATHER CONTACTED THE PHYSICIAN TO SEE WHAT ACTIONS SHOULD BE TAKEN. THE PHYSICIAN ADVISED THEM TO GO TO THE ER FOR MORE IMMEDIATE ASSISTANCE. THE PATIENT'S PARENTS RUSHED THE CHILD TO THE ER WHERE THE PHYSICIANS ORDERED AN X-RAY AND AN ULTRASOUND. THE ULTRASOUND SHOWED AN OBJECT IN THE PATIENT'S BLADDER. PATIENT WAS SENT HOME WITH PRESCRIPTION FOR SUPREX-F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH TIEMAN TAPER-TIP CH08 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5046501400 1638546

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention