BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5431152 · Received February 8, 2016

    Report

    Report Number
    MW5060112
    Event Type
    Injury
    Date Received
    February 8, 2016
    Date of Event
    February 6, 2015
    Report Date
    February 8, 2016
    Manufacturer
    BAYER CORP
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE INSTALLATION WENT WRONG, TOO DEEP INTO THE FALLOPIAN. A NUMBER OF SIDE EFFECTS; PAIN, HEAVY AND IRREGULAR PERIODS, HAIR LOSS, E-BELLY, SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75224 ESSURE ESSURE HHS BAYER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R| S