BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132030-EMS GENERATOR SYSTEM

    MDR report key: 398285 · Received June 3, 2002

    Report

    Report Number
    1213643-2002-00030
    Event Type
    Injury
    Date Received
    June 3, 2002
    Date of Event
    April 26, 2002
    Report Date
    June 3, 2002
    Manufacturer
    DAVOL, INC.(RI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT WAS BURNED. PROCEDURE UTERINE ENDOMETRIAL ABLATION. THIRD DEGREE BURNS TO VAGINAL CANAL, LABIA MAJOR & MINOR AND "INTROAUTUS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 132030-EMS GENERATOR SYSTEM 350101004-SIMPULSE REGULATORS & ACCESS. GEI DAVOL, INC.(RI) * 24384097

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention