BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3900104 · Received June 27, 2014

    Report

    Report Number
    MW5036852
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    February 3, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVER SINCE MY ESSURE WAS IMPLANTED IN (B)(6) 2013 I HAVE BEEN EXPERIENCING HORRIBLE PAIN ALL AROUND THE CENTER OF MY BODY. MOSTLY LOWER ABDOMEN AND BACK. I HAVE ALSO BEEN EXPERIENCING MAJOR HEADACHES AND SHOULDER AND KNEE PAIN ON THE LEFT SIDE OF MY BODY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377725 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 23.000 YR Hospitalization| O