BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4883038 · Received June 24, 2015

    Report

    Report Number
    MW5043362
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    January 1, 2010
    Report Date
    June 24, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REDUCED TO NO SEX DRIVE, HORMONAL IMBALANCES, DEPRESSION, MOOD SWINGS, VISION AND DENTAL ISSUES, ACNE, FORGETFULNESS "BRAIN FOG", ARM AND LEG NUMBNESS AND TINGLING, HAIR LOSS, LOWER BACK PAIN, ABD PAIN AND CRAMPING, BLEEDING, GASTRO ISSUES, LOSS OF ENERGY, SHAKING AN UNSTEADY HANDS, INCREASED SWEATING, BLADDER ISSUES. RX MEDS: ESSURE STILL IMPLANTED. OTC MEDS: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407851 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention| S