BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913618 · Received June 30, 2014

    Report

    Report Number
    MW5037044
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BAYER HEALTH
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE COILS PLACED IN (B)(6) 2011 AND ALSO HAD THE DIE TEST DONE ABOUT 5 MONTHS LATER AND EVERYTHING HAS SEEMED OKAY UNTIL I STARTED TO PUT MY SYMPTOMS TO DATE. ALL WERE AFTER THE COILS WERE PLACED. I CURRENTLY STILL HAVE THE COILS IN PLACE BUT I AM TRYING TO FIND A DOCTOR THAT WILL REMOVE THEM. THE PROBLEMS I AM HAVING ARE SEVERE BLOATING TO THE POINT I LOOK PREGNANT, AND PAIN OCCASIONALLY, HEAVIER PERIODS THAN I HAVE EVER HAD, AND I WAS RECENTLY DIAGNOSED WITH IBS AND THAT IS SOMETHING I'VE NEVER HAD. THESE COILS NEED TO BE TAKEN OFF THE MARKET AND CURRENT PATIENTS WITH THEM SHOULD NOT HAVE SUCH A HARD TIME FINDING A DOCTOR TO GET THEM OUT! THESE ARE A NIGHTMARE AND IF I KNEW ALL OF THIS BEFORE I HAD THEM PLACED I WOULD NEVER HAVE GOTTEN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379149 ESSURE NONE HHS BAYER HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| S