BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3610862 · Received January 29, 2014

    Report

    Report Number
    2951250-2014-00009
    Event Type
    Injury
    Date Received
    January 29, 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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE RECEIVED THE ESSURE COIL IMPLANTS AND SUFFERED COMPLICATIONS (NOT OTHERWISE SPECIFIED) AND HORRIBLE PAIN OVER A SPAN OF TWO YEARS THAT EVENTUALLY LED TO A HYSTERECTOMY WITH REMOVAL OF ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62573 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention