BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER RED RUBBER CH14

    MDR report key: 2063588 · Received April 19, 2011

    Report

    Report Number
    2183558-2011-00015
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    March 21, 2011
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN 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.

    Description of Event or Problem · 1

    (B)(6). ACCORDING TO THE INFORMATION RECEIVED, A PATIENT USES THE CATHETERS TO DRAIN A STOMA. HAS DIFFERENT SIZE CATHETERS IN THE SAME BOX. MOST OF THE CATHETERS IN THE BOX ARE TOO BIG AND CAUSING SOME BLEEDING IN THE STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER RED RUBBER CH14 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC UC10141400 402355R002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention