BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTICULATOR 35

    MDR report key: 280031 · Received May 25, 2000

    Report

    Report Number
    1824347-2000-00015
    Event Type
    Other
    Date Received
    May 25, 2000
    Report Date
    April 28, 2000
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTICULATOR 35 DID NOT CLIP PERFECTLY. THIS CAUSED EXTRACORPORAL ANASTOMOSIS. PT WAS TREATED WITH IRRIGATION AND DRUGS. PT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATOR 35 ARTICULATOR 35 GAG IMAGYN SURGICAL 4335 02M99

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other