BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913190 · Received June 27, 2014

    Report

    Report Number
    MW5037022
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    August 22, 2013
    Report Date
    June 26, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS ESSURE IMPLANTED ON (B)(6) 2013. IMMEDIATELY FOLLOWING AND SINCE THEN, I HAVE HAD DEBILITATING SIDE EFFECTS. I DEAL WITH MIGRAINES, STABBING PAINS, CRAMPING, EXCESSIVE BLEEDING DURING "MONTHLY", NAUSEA, DIARRHEA, DIZZINESS, HEAD FOG, DEPRESSION, MOOD SWINGS, TINGLING IN HANDS AND FEET, JOINT PAIN, AND BLOATING. I AM ALLERGIC TO NICKEL AND WAS NOT TOLD THAT THIS PRODUCT CONTAINED NICKEL. I HAD MY HSG AND I HAVE A BROKEN COIL, MY COILS ARE TOO FAR INTO UTERUS, AND I NOW HAVE AN ANTEFLEXED UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376257 ESSURE ESSURE HHS BAYER ESS306 B30422

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR