BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3716104 · Received March 20, 2014

    Report

    Report Number
    2951250-2014-00070
    Event Type
    Injury
    Date Received
    March 20, 2014
    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 REPORTED VIA (B)(4) THAT SHE HAD ESSURE INSERTED AND THAT SHE HAD TO UNDERGO A FULL HYSTERECTOMY AFTER ESSURE "TORE THROUGH HER INTERNAL ORGANS, ABSCESSED AND CAUSED SEPSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165248 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention