BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6017558 · Received October 11, 2016

    Report

    Report Number
    MW5065301
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    October 10, 2011
    Report Date
    September 29, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). ESSURE INSERTED (B)(6) 2011. WITHIN A YEAR, SYMPTOMS APPEARED: PELVIC PAIN, BACK PAIN, BODY ACHES, NAUSEA, DIGESTIVE ISSUES, BOWEL CHANGES, HEADACHES, FOOD SENSITIVITIES, SKIN RASH AND SENSITIVITIES, LOSS OF LIBIDO, NO ENERGY, BRAIN FOG, MUSCLE CRAMPS, HYPERTHYROIDISM, WEIGHT GAIN, DIZZINESS, DEPRESSION, MOOD SWINGS, ALLERGIES, DENTAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669041 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 43.000 YR Required Intervention