BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5761303 · Received June 30, 2016

    Report

    Report Number
    MW5063159
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    May 14, 2014
    Report Date
    June 29, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4). CONNECTIVITY MUSCLE, PELVIC PAIN, MIGRAINES UROLOGICAL MENES BRAIN FOG, DEPRESSION, ANXIETY PAIN "RELAPSE" OF MULTIPLE SCLEROSIS. WAS PUT ON NUMEROUS MEDICATION. HEAT STOKE, MIGRAINES VOMITING, HYPERSENSITIVITY NUMBNESS RASHES MUSCLE WEAKNESS INSOMNIA PSYCH WARD DUE TO MAJOR CHRONIC DEPRESSION ALSO BONE DEGENERATIVE DISEASE. I STILL DON'T HAVE FULL USE OF MY FACULTIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 09/22/2016 FOR REPORT #MW5063159 FROM REPORTER. THE REPORTER STATED AS I GET BETTER MY MEMORY IS RETURNING. AFTER THE IMPLANT I HAD ABDOMINAL PAIN, CRAMPING, MY FLEXIBILITY AND MOVEMENT WAS DECREASED, SWEATING PROFUSELY TO THE POINT THAT I NEEDED TO USE ICE PACKS, AUDIOVISUAL DISTURBANCES. NINETY FIVE PERCENT OF THE DEVICE HAS BEEN REMOVED BUT I STILL HAVE A FRAGMENT IN ME. I WOULD SLEEP FOR 20 HOURS A DAY, WAS FATIGUED ALL THE TIME, HAD SORES, RASHES, AND PAIN IN MY CHEST. I WAS BEING FOLLOWED FOR MY MS AND MY REGULAR HEARTRATE (HR) IS 99-102 RESTING. DURING SURGERY IN (B)(6) MY HR WENT TO 72. MY HR IS STARTING TO INCREASE AGAIN BECAUSE OF INFLAMMATION BUILDING IN MY CHEST.

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4). CONNECTIVITY MUSCLE, PELVIC PAIN, MIGRAINES UROLOGICAL MENES BRAIN FOG, DEPRESSION, ANXIETY PAIN "RELAPSE" OF MULTIPLE SCLEROSIS. WAS PUT ON NUMEROUS MEDICATION. HEAT STOKE, MIGRAINES VOMITING, HYPERSENSITIVITY NUMBNESS RASHES MUSCLE WEAKNESS INSOMNIA PSYCH WARD DUE TO MAJOR CHRONIC DEPRESSION ALSO BONE DEGENERATIVE DISEASE. I STILL DON'T HAVE FULL USE OF MY FACULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415603 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    0 45.000 YR Hospitalization
    1 45.000 YR Hospitalization