BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE IMPLANTATION DEVICE

    MDR report key: 5029125 · Received August 18, 2015

    Report

    Report Number
    MW5055711
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    June 23, 2015
    Report Date
    August 18, 2015
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) OF 2006 I HAD THE ESSURE PUT IN TO PREVENT PREGNANCY IN (B)(6) OF 2007, I GAVE BIRTH TO MY SON I WAS TOLD THE SCAR TISSUE AROUND THE COIL DIDN'T FULLY HEAL. I LATER HAD A SCAN DONE AGAIN TO CONFIRM THE SCAR TISSUE STILL HASN'T HEALED. I GOT PREGNANT AGAIN IN 2011, BUT HAD TO TERMINATE THE PREGNANCY. THIS PAST (B)(6) OF 2015, I GAVE BIRTH TO A BABY BOY I SIGNED PAPERS TO HAVE A TUBAL LIGATION. I WAS INFORMED WHEN I WENT IN FOR MY F/U THAT MY TUBE WAS NEVER BLOCKED THAT THE COIL WAS IMBEDDED ON THE SURFACE OF MY UTERUS. I HAVE SINCE REALIZED THAT THIS COULD HAVE BEEN THE CAUSE FOR MY PAINFUL PERIODS AND SEXUAL INTERCOURSE BUT ALSO MANY HARMFUL THINGS COULD HAVE HAPPENED TO MY UTERUS THE FACT THAT THE COIL WAS NEVER IN MY TUBE HAS FRUSTRATED ME, I HAVE TWO BEAUTIFUL CHILDREN THAT I LOVE DEARLY BUT THE PURPOSE OF THE ESSURE WAS SO I COULDN'T HAVE ANY MORE CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544437 ESSURE IMPLANTATION DEVICE ESSURE IMPLANTATION DEVICE HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention