BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5454927 · Received February 18, 2016

    Report

    Report Number
    MW5060409
    Event Type
    Injury
    Date Received
    February 18, 2016
    Date of Event
    November 15, 2014
    Report Date
    February 18, 2016
    Manufacturer
    BAYER CORP
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UNABLE TO WORK, OR DO ALMOST ANYTHING (AT HOME ETC.) LEGS AND ARMS HAVE PAIN, GET NUMB, TINGLE, STRENGTHLESS; HEADACHE, OVULATION PAIN, PROBLEMS IN MENSTRUATION, BACKACHE, PELVIS ACHE. DEPRESSION, INEFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102792 ESSURE ESSURE HHS BAYER CORP ESS305 77437, 3

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability