BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113727 · Received September 24, 2014

    Report

    Report Number
    MW5038269
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 21, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4). I HAD THE ESSURE PROCEDURE BACK IN (B)(6) 2012 TO PREVENT PREGNANCY. I STARTED HAVING ISSUES RIGHT AWAY, HEAVY BLEEDING, PERIODS EVERY 3 WEEKS, HORRIBLE CRAMPS, ABDOMINAL PAIN, BACK PAINS, LEG PAIN, DEPRESSION, ANXIETY, PANIC ATTACKS, HAIR LOSS, PAINFUL INTERCOURSE, LOSS OF SEX DRIVE AND ADENOMYOSIS LEADING TO LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2014 AT ONLY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594831 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Hospitalization