BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3718058 · Received March 25, 2014

    Report

    Report Number
    2951250-2014-00086
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    May 26, 2011
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER HAD ESSURE IMPLANTED. ON (B)(6) 2011, ESSURE PERFORATED TUBE, CAUSED SCAR TISSUE, WHICH CAUSED ORGANS TO FUSE TOGETHER. CONSUMER HAD TO HAVE TOTAL ABDOMINAL HYSTERECTOMY WITH REMOVAL OF TUBES AND ONE OVARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173548 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention