BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5212159 · Received November 9, 2015

    Report

    Report Number
    MW5057760
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    June 9, 2008
    Report Date
    November 4, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). PAINFUL, HEAVY PERIODS, DIARRHEA, VOMITING, WEIGHT GAIN. I HAD A HYSTERECTOMY, SALPINGO-OOPHORECTOMY OF MY RIGHT OVARY BECAUSE OF ADENOMYOSIS AND ENDOMETERIOSIS. I HAVE HAD A CYSTECTOMY ON THE LEFT OVARY THIS YEAR. I HAVE DEVELOPED HYPOTHYROIDISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740492 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 44.000 YR Hospitalization| O| S