BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3952624 · Received July 18, 2014

    Report

    Report Number
    MW5037347
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HYSTERECTOMY TO REMOVE ESSURE. AFTER I HAD THE ESSURE PROCEDURE, I HAD THE FOLLOWING: SEVERE BACK PAIN, FOLLOWED BY DOCTOR VISITS, CORTISONE SHOTS, MRI'S AND THERAPY. BAD MIGRAINES, CRAMPING, EXCESSIVE BLEEDING, PELVIC PAIN, HAIR LOSS, WEIGHT GAIN, BRAIN FOG, BLOATING AND IRRITABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423225 ESSURE NONE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention