BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3875300 · Received June 16, 2014

    Report

    Report Number
    MW5036612
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    October 5, 2011
    Report Date
    May 19, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS TOLD PROCEDURE WOULD TAKE 15 MINUTES BUT TOOK 4 HOURS. I WAS IN SO MUCH PAIN AND KEPT CALLING DR WHO IGNORED ME. CALLED ANOTHER DR AND HE HAD ME COME IN FOR SURGERY IMMEDIATELY TO REMOVE COILS. COULDN'T FIND THEM SINCE THEY MIGRATED AFTER 2 MONTHS. HAD TO HAVE TUBES REMOVED. FOUND FERTILIZED EGG AND THREE COILS. DR WHO DID ESSURE LIED IN HIS REPORT AS SAID HE INSERTED TWO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352600 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 46.000 YR Hospitalization| O