BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913162 · Received June 27, 2014

    Report

    Report Number
    MW5037019
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    August 23, 2012
    Report Date
    June 26, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE IMPLANTED (B)(6) 2012. I HAVE EXPERIENCED RASH, HORRIBLE BACK PAIN WITH PAIN UNDER MY RIBS, LIGHTHEADEDNESS, MOOD SWINGS, FIBROIDS WHERE THE TUBE IS, ENDOMETRIOSIS. I NOW HAVE TO HAVE SURGERY NEXT MONTH TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376227 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention| S