BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3833908 · Received May 27, 2014

    Report

    Report Number
    MW5036233
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    July 7, 2012
    Report Date
    January 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE IN (B)(6) 2012. SEVERAL WEEKS AFTERWARDS, I EXPERIENCED EXTREME HEADACHES. I WENT TO MY REGULAR FAMILY DOC AND HE SAID HE HADN'T HEARD OF ESSURE AND IT WAS PROBABLY DUE TO STRESS. WOULD TAKE PAIN KILLERS DAILY, DIDN'T ALWAYS WORK. PERIOD IS SO IRREGULAR, I USUALLY START FOR A DAY, THEN STOP FOR TWO, THEN START BACK UP FOR A WEEK. VERY HEAVY. PAIN IN LOWER BACK AND ABS. ODD TASTE IN MOUTH. (B)(4). MW5034386 UPDATE ON (B)(6) 2014: ON (B)(6) 2014, I HAD THE ESSURE COILS REMOVED BY DR (B)(6). I HAD A PRE-OP APPOINTMENT PLUS MY SURGERY WHICH CONSISTED OF QUITE A DRIVE TO (B)(6), BUT SO WORTH IT. THE DOCTOR SAID SHE FOUND SOME ENDOMETRIOSIS DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311656 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 33.000 YR ESSURE