BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3793899 · Received May 6, 2014

    Report

    Report Number
    MW5035935
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 27, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON (B)(6) 2015: IT'S BEEN TWO MONTHS AND STILL HAVE PAIN. I HAVE GONE BACK TO THE ER HOPING FOR AN ANSWER WHY I'M STILL HAVING ISSUES. NEW SYMPTOMS HIPS DOWN TO MY FEET, SHARP PAIN. I CAN SIT DOWN FOR 30 MINUTES AND TRYING TO GET UP, MY LEGS ARE NUMB AND PAINFUL SO I'M NEEDING TO GET UP . TWO MONTHS HERE WITH ESSURE AND STILL NOT ABLE TO EAT MEAT, ODDLY IT MAKES ME NAUSEOUS.

    Description of Event or Problem · 1

    IN 3 WEEKS: I HAVE VISITED THE ER AND DOCTORS 10 TIMES. CONTINUE TO HAVE DULL PAIN CONSTANTLY, IRREGULAR SHARP PAINS, BLOATING, PANIC ATTACKS, MIGRAINES, NAUSEOUS AND VOMITING, COMPLEX OVARIAN CYST, TIREDNESS, LONG/ SHORT TIME MEMORY LOSS, NIGHT SWEATS, EMOTIONS OF ANY KIND MAKES ME SWEAT, HEART RACING, SHORTNESS OF BREATH, JOINTS, HIP AND BACK PAIN, INSOMNIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270347 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 44.000 YR Hospitalization| S