BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMATIC RING

    MDR report key: 1408672 · Received June 30, 2009

    Report

    Report Number
    MW5011691
    Event Type
    Injury
    Date Received
    June 30, 2009
    Date of Event
    May 31, 2009
    Report Date
    June 24, 2009
    Manufacturer
    NITI SURGICAL SOLUTIONS
    Product Code
    LNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2009, PT UNDERWENT SIGMOID COLECTOMY FOR NEWLY DIAGNOSED COLON CANCER. COMPRESSION ANASTOMOSIS RING INSERTED AT THAT TIME. TWO DAYS LATER, DISCHARGED HOME WITHOUT COMPLICATIONS. AT ABOUT 3 DAYS LATER, PRESENTED TO ED WITH C/O OF "CONSTIPATION AND FULL BLADDER" AND WAS ADMITTED TO HOSPITAL. ABDOMEN DISTENDED AND TENDER - CT SHOWED FLUID IN ABDOMEN. IN THE SAME DAY, RETURNED TO OR FOR ACUTE SURGICAL ABDOMEN AND POSSIBLE ANASTOMOTIC LEAK. UNDERWENT DIAGNOSTIC AND EXPLORATORY LAPAROSTOMY AND COLOSTOMY, COMPRESSION RING REMOVED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMATIC RING CAR 27 RING LNN NITI SURGICAL SOLUTIONS CAR27

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention