BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTICULATOR 35

    MDR report key: 287393 · Received July 26, 2000

    Report

    Report Number
    1824347-2000-00021
    Event Type
    Other
    Date Received
    July 26, 2000
    Report Date
    June 27, 2000
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL ABDOMINAL HYSTERECTOMY, BLEEDING OCCURRED, WHILE USING ARTICULATOR 35. SURGEON HAD TO SUCTION AND SUTURE TO FINISH PROCEDURE. NO ADVERSE AFFECT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATOR 35 ARTICULATOR 35 GAG IMAGYN SURGICAL 4325 01F00

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other