BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 1970395 · Received January 17, 2011

    Report

    Report Number
    2951250-2011-00001
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 18, 2010
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED PAIN TEN DAYS FOLLOWING AN ESSURE MICRO-INSERT PLACEMENT PROCEDURE. A CT SCAN WAS PERFORMED AND IT WAS OBSERVED THAT THE MICRO-INSERT ON THE PT'S LEFT SIDE HAD POSSIBLY BROKEN INTO 2 PIECES. A LAPAROSCOPY WAS PERFORMED TO REMOVE THE MICRO-INSERT ON THE LEFT SIDE. THE MICRO-INSERT WAS FOUND INTACT AND TO HAVE PERFORATED THE FALLOPIAN TUBE; THE INNER COIL OF THE MICRO-INSERT WAS WRAPPED IN THE PT'S BOWEL. THE PHYSICIAN REPORTED THE PT'S STATUS AS "FINE" FOLLOWING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention