BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5320384 · Received December 22, 2015

    Report

    Report Number
    MW5058685
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    June 9, 2011
    Report Date
    December 21, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). BLOATING, HEADACHES, ABNORMAL MENSTRUAL CYCLE, PELVIC PAIN, HOT FLASHES, SEIZURE, SEVER BACK PAIN, DEPRESSION, MOOD SWINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845184 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Hospitalization| S