BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3080352 · Received April 22, 2013

    Report

    Report Number
    MW5029914
    Event Type
    Other
    Date Received
    April 22, 2013
    Date of Event
    December 1, 2007
    Report Date
    April 22, 2013
    Manufacturer
    CONCEPTUS INC.
    Product Code
    HHS
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROCEDURE DONE IN DECEMBER OF 2007 HORRIBLE PAIN DURING OVULATION, MIGRAINES, 33 CONSISTENT DAYS OF BLEEDING AFTER 3 YEARS HAVING ESSURE. ENDOMETRIAL ABLATION DONE. DIDN'T WORK STILL. BLEEDING AND HORRIBLE PMS, WEIGHT GAIN, BLOATING, MIGRAINES BEFORE AND AFTER PERIODS EVERY MONTH, BACTERIAL INFECTIONS ALL THE TIME. YEAST INFECTIONS CONSTANTLY. CONSTANT THIGH/UPPER MUSCLE SPASMS. ENDOMETRIOSIS NOW FROM SCAR TISSUE. DOCTOR HAS ME TAKING 200 MILLIGRAMS OF ORAL FLAGYL AFTER EVERY PERIOD AND DIFLUCAN BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171534 ESSURE ESSURE HHS CONCEPTUS INC. IL2843 628647
    171575 ESSURE ESSURE HHS CONCEPTUS INC. ES6305 625647

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other