BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3884414 · Received June 19, 2014

    Report

    Report Number
    MW5036670
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 11, 2012
    Report Date
    June 8, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MOODINESS, DEPRESSION, SUICIDAL THOUGHTS, BLOATING, ALLERGIES, HEADACHES, FATIGUE, CHRONIC ABDOMINAL CRAMPING, HEAVY PERIODS, IRREGULAR PERIODS, PAIN ON RIGHT SIDE OF ABDOMEN, MIGRATION OF ESSURE COIL, ESSURE COIL PROTRUDING THROUGH RIGHT FALLOPIAN TUBE, RASH, ITCHING, HYSTERECTOMY ON (B)(6) 2014, FRAGMENT SURGERY ON (B)(6) 2014. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361675 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR Hospitalization| O| S NAPROXIN, TYLENOL, IBUPROFIN