BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4905229 · Received July 10, 2015

    Report

    Report Number
    MW5043865
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    September 19, 2014
    Report Date
    June 8, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). LEFT HIP WAS SORE, PAIN WAS ON AND OFF FOR AROUND 1 MONTH. FELT AS THOUGH I HAD SLEPT ON A CONCRETE FLOOR. THEN THE PAIN/SORENESS TURNED TO EVERY DAY SINCE. SHARP ABDOMINAL PAINS ABOUT TWICE A MONTH SINCE INSERTION. MUSCLE FATIGUE BECAME NOTICEABLE ABOUT A MONTH AFTER THE INSERTION. THE AMOUNT OF WEIGHT I WAS LIFTING AT THE GYM DETERIORATED TO 1/2 THE AMOUNT I WAS ABLE TO BEFORE. SLEEPINESS AT ALL TIMES OF THE DAY. I HADN'T BEEN THAT TIRED SINCE PREGNANCY. I COULD FALL ASLEEP STANDING UP I BELIEVE. WEIGHT GAIN OF 16 POUNDS IN 3 MONTHS EVEN THOUGH THERE WAS NO CHANGE IN DIET OR EXERCISE. FIRST PERIOD AFTER INSERTION AND EACH ONE THERE AFTER LASTS 7-8 DAYS AND IS EXTREMELY HEAVY WITH LARGE CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450374 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 45.000 YR Other