BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7424958 · Received April 11, 2018

    Report

    Report Number
    MW5076450
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    August 1, 2014
    Report Date
    August 10, 2018
    Manufacturer
    BAYER CORP.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE BIRTH CONTROL IMPLANTED IN (B)(6) 2014. I BELIEVE IT WAS, WORST DECISION EVER. ON THURSDAY (B)(6) 2018 I AM HAVING A HYSTERECTOMY DONE BECAUSE OF ALL THE COMPLICATIONS I HAVE HAD SINCE GETTING THE BIRTH CONTROL DEVICE. I CONTRACTED LUPUS AND RHEUMATOID ARTHRITIS, WEIGHT GAIN, HEAVY BLEEDING, CRAMPING IN ABDOMINAL AREA, LIST GOES ON AND ON. I REFUSE TO TAKE STEROIDS FOR MY LUPUS/RHEUMATOID ARTHRITIS PAIN. I AM JUST GETTING THE DEVICE REMOVED SO MY HEALTH GOES BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264672 ESSURE TRANSCERVICAL, CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization