BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODYNAMIX ANASTOMOSIS WITH COLONRING

    MDR report key: 1571211 · Received December 30, 2009

    Report

    Report Number
    MW5014188
    Event Type
    Injury
    Date Received
    December 30, 2009
    Date of Event
    December 16, 2009
    Report Date
    December 30, 2009
    Manufacturer
    NITI SURGICAL SOLUTIONS
    Product Code
    LNN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL CONNECTION OF TWO ENDS OF COLON, A PRODUCT CALLED THE COLONRING WAS UTILIZED TO MAINTAIN ANASTOMOSIS. POST OP DAY 1 FEVERS TO 104 ALONG WITH ILEUS. IN 2009, CT INDICATED CONCERN FOR ANASTOMOTIC LEAK. CT THE FOLLOWING DAY, CONFIRMED A ANASTOMATIC LEAK AND PT RETURNED TO SURGERY. PERITONITIS OBVIOUS ALONG WITH LEAK POSSIBLY DUE TO FAILURE OF COLONRING. REPAIR RESULTED IN COLOSTOMY WITH SURGICAL WOUND LEFT OPEN FOR SUBSEQUENT TREATMENT MODALITIES. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TO CONNECT TWO ENDS OF RESECTED BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODYNAMIX ANASTOMOSIS WITH COLONRING CAR 27 LNN NITI SURGICAL SOLUTIONS 43271163

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization