BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3875655 · Received June 16, 2014

    Report

    Report Number
    MW5036625
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DO NOT HAVE ANY ONGOING ILLNESSES, I DO NOT TAKE ANY MEDICATIONS. I GOT THE ESSURE IN EARLY TO MID (B)(6) 2014. I HAVE BEEN HAVING A MILD TO SEVERE PAIN IN MY LOWER ABDOMEN FOR THE PAST 3 WEEKS, I HAVE BEEN HAVING HORRIBLE HEADACHES SINCE I HAVE GOTTEN THE ESSURE AS WELL AS SHARP PAINS SOMETIMES IN MY LEGS AND OTHER TIMES IN MY SIDE. IVE GAINED AT LEAST 10 POUNDS IN THE PAST MONTH. I DO HAVE A NICKEL ALLERGY AND WAS NOT TOLD THAT ESSURE HAS NICKEL IN IT OR ELSE I WOULD HAVE WENT A DIFFERENT ROUTE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353081 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 29.000 YR Other