BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5357400 · Received January 11, 2016

    Report

    Report Number
    MW5059140
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    June 1, 2015
    Report Date
    January 9, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). MY INSURANCE COMPANY COVERED THE ESSURE PROCEDURE. SHORTLY AFTER GETTING ESSURE IMPLANTED MY PERIODS WERE VERY HEAVY AND IRREGULAR. I WOULD GO MONTHS WITHOUT A PERIOD BUT STILL HAD EXTREME MONTHLY CRAMPING. WHEN I DID GET MY PERIOD IT WOULD LAST FOR 10-20 DAYS. IT WOULD BE EXTREMELY HEAVY WITH HUGE CLOTS AND THE CRAMPING WOULD BE VERY PAINFUL. REGULAR HEADACHES, WEIGHT GAIN, HAIR LOSS, DENTAL ISSUES, SKIN RASHES, MUSCLE CRAMPS, STABBING SIDE CRAMPS, MOOD SWINGS ARE SOME OF THE SIDE EFFECTS I DEAL WITH ON A REGULAR BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17187 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 37.000 YR Other