BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAL-TRAY

    MDR report key: 18082 · Received October 3, 1994

    Report

    Report Number
    18082
    Event Type
    Injury
    Date Received
    October 3, 1994
    Date of Event
    September 27, 1994
    Report Date
    September 30, 1994
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    FJX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 9/20/94 PT HAD A SMALL BOWEL RESECTION FOR CARCINOID TUMOR. ON 9/27/94 PT UNDERWENT 2ND SURGERY FOR ACUTE ABDOMEN, POSSIBLE BOWEL PERFORATION. THERE WAS LEAKAGE OF FOOD MATERIAL AROUND THE ANASTOMOSIS. THIS CONSISTED MAINLY OF FIBROUS MATERIAL AND CORN. FINAL DX: PERFORATION OF SMALL BOWEL AT THE SITE OF PREVIOUS ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAL-TRAY Implant BIOFRAGMENTABLE ANASTOMOSIS RING FJX DAVIS & GECK, INC. 8083-00

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention