BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1503626 · Received October 9, 2009

    Report

    Report Number
    2951250-2009-00057
    Event Type
    Injury
    Date Received
    October 9, 2009
    Date of Event
    September 10, 2009
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IFU STATEMENT: THERE ARE NO DATA TO SUPPORT THE USE OF ABLATIVE TECHNOLOGIES CONCOMITANTLY WITH ESSURE, THEREFORE IT IS NOT RECOMMENDED. IFU WARNING: DO NOT PERFORM THE ESSURE PROCEDURE CONCOMITANTLY WITH ENDOMETRIAL ABLATION.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    PT UNDERWENT AN ESSURE IMPLANTATION PROCEDURE AND A NOVASURE ABLATION PROCEDURE CONCOMITANTLY IN 2009. PT COMPLAINED OF SEVERE PAIN FOLLOWING PROCEDURES (DATE OF ONSET AND FREQUENCY UNK).THE PHYSICIAN ATTEMPTED TO MANAGE PAIN WITH NSAIDS AND ANTIBIOTICS; PAIN PERSISTED DESPITE TREATMENT. THE FOLLOWING MONTH, THE ESSURE MICRO-INSERTS WERE REMOVED. FOLLOWING REMOVAL, PAIN RESOLVED AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 646531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention