BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5454062 · Received February 23, 2016

    Report

    Report Number
    MW5060346
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    June 10, 2013
    Report Date
    February 11, 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). MY DEVICE WAS NOT COVERED BY I INSURANCE. CRAMPS HAVE BECOME UNBEARABLE, PASSING GAME HEAVY CLOTS. MORE AND MORE EACH MONTH. HEADACHES, NAUSEA, GAS, BLOATING, PAINFUL SEX, SHARP STABBING PAINS, CRAMPS KEEP GETTING WORSE. HIVES, RASHES. DRY SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109552 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 38.000 YR Other