BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4905231 · Received July 10, 2015

    Report

    Report Number
    MW5043866
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    December 10, 2013
    Report Date
    June 8, 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). EXTREME PAIN TO THE ABDOMEN. INSOMNIA. WEAK BLADDER. WEIGHT GAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449658 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Other