BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SELF CATH FEMALE CH14

    MDR report key: 2770973 · Received October 3, 2012

    Report

    Report Number
    3005945907-2012-00028
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 4, 2012
    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 OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED A USER REPORTED THAT SOME CATHETERS FEEL ROUGH. THE USERS SOMETIMES BLEEDS WHEN SHE REMOVES THE CATHETER. THE USER STATED THAT THE CATHETERS ARE UNCOATED AND SHE IS NOT USING ANY LUBRICANT. THE END USER HAS SPOKEN TO A DOCTOR ABOUT THIS ISSUE. SHE CURRENTLY HAS A UTI AND IS ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF CATH FEMALE CH14 INTERMITTENT CATHETER KOD COLOPLAST A/S 5046301400 3114510

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other