BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3983113 · Received August 6, 2014

    Report

    Report Number
    MW5037597
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 6, 2011
    Report Date
    July 31, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). AFTER THE SPRINGS WERE PLACED, I HAD CONSTANT CRAMPING/SHARP PAINS IN THE PELVIC AREA. I ALSO HAD CONSTANT BLEEDING. HAD A ABLATION AFTERWARDS AND STILL HAD THE PAIN. COME TO FIND OUT, ONE OF THE SPRINGS WAS PERFORATING MY UTERUS. ENDED WITH A HYSTERECTOMY. ALL I HAVE NOW IS AN OVARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461335 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Hospitalization| S