BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALTRAC

    MDR report key: 152048 · Received October 17, 1997

    Report

    Report Number
    1210157-1997-00006
    Event Type
    Injury
    Date Received
    October 17, 1997
    Report Date
    September 19, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    LNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTS, ONE PT HAD A RELAPAROTOMY FOR ANASTOMOTIC COMPLICATIONS RESULTING FROM THE USE OF ANASTOMOSIS RING DURING HIGH RISK COLONIC RESECTION. THE PT WHO HAD PRE-EXISTING CROHN'S DISEASE, WAS OPERATED SOME SIX MONTHS POST-OP FOR AN ANSTOMOTIC STRICTURE. AT RELAPAROTOMY, A SHORT, FIBROTIC AND NARROW STRICTURE FOUND AT THE SITE OF THE FORMER ANASTOMOSIS WAS RESECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention