BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALTRAC

    MDR report key: 57214 · Received December 20, 1996

    Report

    Report Number
    1210157-1996-90001
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    October 5, 1996
    Report Date
    November 20, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    LNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 58 YR OLD MALE UNDERWENT AN APPENDECTOMY AND SIGMOID RESECTION UTILIZING VALTRAC FOR COLORECTAL ANASTOMOSIS. FOLLOWING VALTRAC CLOSURE, SUTURES WERE USED TO REINFORCE A BRUISED AREA AT THE DISTAL PART OF THE ANASTOMOSIS. FIVE DAYS POSTOPERATIVELY, THE PT DEVELOPED ABDOMINAL PAIN AND SHORTNESS OF BREATH. GASTROGRAFIN ENEMA CONFIRMED LEAKAGE OF THE ANASTOMOSIS. THIS NECESSITATED REOPERATION TO REMOVE THE VALTRAC, AND THE PERFORMANCE OF COLOSTOMY FOR THE PT. THE PT WAS PUT ON ANTIBIOTICS AND DISCHARGED EIGHT DAYS LATER. THE PT IS DOING WELL, AND WILL RETURN IN JANUARY, 1997 FOR REVERSE FOR THE COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALTRAC BIOFRAGMENTABLE ANASTOMOSIS RING LNN SHERWOOD DAVIS AND GECK NA 889643

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention