BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3718063 · Received March 20, 2014

    Report

    Report Number
    2951250-2014-00075
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    November 7, 2013
    Report Date
    April 10, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 FDA (B)(4) THAT SHE HAD ESSURE INSERTED AND THAT SINCE THAT TIME SHE HAS HAD HORRIBLE BLEEDING, CLOTTING, AND SEVERE PAIN. REPORTEDLY, SHE "HAD NO OTHER OPTION EXCEPT HYSTERECTOMY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165761 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 50712464

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other| R IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| MOBIC| MOBIC| MOBIC| MOBIC| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT