BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING

    MDR report key: 2853155 · Received July 29, 2008

    Report

    Report Number
    3005278776-2008-00003
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION OR REMEDIAL ACTIONS.

    Description of Event or Problem · 1

    ANASTOMOTIC LEAK - ON DAY 5 AFTER SURGERY THE PATIENT FELT BAD. PROF. STIFT DECIDED TO REOPERATE HER. AFTER HE OPENED HER AND GOT TO THE ANASTOMOSIS THE PROXIMAL COLON WAS FULLY OPENED. HE CUT THE RING AND PERFORMED HARTMANN COLOSTOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING CAR 27 FZP NITI SURGICAL SOLUTIONS LTD. 43271101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization