BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYSTOCARE CATHETER INSERTION TRAY

    MDR report key: 2000671 · Received February 24, 2011

    Report

    Report Number
    2183558-2011-00010
    Event Type
    Death
    Date Received
    February 24, 2011
    Report Date
    February 18, 2011
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HOME HEALTH AIDE

    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. DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER DID NOT SPECIFY THAT EXACT DATE IN WHICH DEATH OCCURRED HOWEVER, DID STATE THAT DEATH OCCURRED 6 MONTHS AGO. BEST ESTIMATE OF EVENT IS (B)(6) 2010. ACCORDING TO THE INFORMATION RECEIVED, THE HOME HEALTH AIDE REPORTED THAT HER PATIENT HAD USED THE UT7010 TRAY WHICH CONTAINS A STERILE LUBRICANT (SUBJECT TO THE TRIAD RECALL). THE HEALTH AIDE BELIEVES THIS COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH WHICH HAPPENED APPROXIMATELY 6 MONTHS AGO. THE HOME HEALTH AIDE STATED THAT THE DEATH CERTIFICATE SPECIFIES- PASSED AWAY DUE TO SEPTIC SHOCK, URINARY TRACT INFECTION AND INDWELLING CATHETER. HEALTH AIDE ALSO STATED PATIENT HAD VULVAR CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYSTOCARE CATHETER INSERTION TRAY CATHETER INSERTION TRAY FCM COLOPLAST MANUFACTURING US, LLC UT70101400 1003049

    Patients

    Seq Age Sex Outcome Treatment
    1 Death