BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYSTOCARE GOLD

    MDR report key: 1896936 · Received November 11, 2010

    Report

    Report Number
    2183558-2010-00046
    Event Type
    Injury
    Date Received
    November 11, 2010
    Report Date
    April 13, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    NNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED INDICATED THERE ARE NO SAMPLES TO RETURN FOR EVALUATION. 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, DURING A OPERATION FOR THE RESECTION OF A BLADDER TUMOR, A LEG COLLAPSED (FIRST USING). THIS RESULTED IN A BLOCKED CATHETER SO THERE WAS URINARY RETENTION AND CLOT FORMATION. THE BAG WAS CHANGED AND NO PRODUCT WAS KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYSTOCARE GOLD URINE LEG BAG NNW COLOPLAST MANUFACTURING US, LLC UB04201002 1507517

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention