BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910710 · Received July 2, 2014

    Report

    Report Number
    MW5037010
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 27, 2012
    Report Date
    June 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE HAVING THE ESSURE PUT IN, I WAS BLEEDING FOR MONTH'S LATER ALONG WITH SEVERE PAINS. I WAS HAVING BLOOD CLOTS THE SIZE OF LEMONS. DIZZINESS, WEIGHT GAIN, LOSS OF SEX DRIVE, AND IN (B)(6) 2014 I HAD TO HAVE A FULL VAGINAL ASSIST HYSTO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386951 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Hospitalization| O