BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4092973 · Received September 10, 2014

    Report

    Report Number
    MW5038173
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF LEFT FALLOPIAN TUBE, BAYER HEALTHCARE LLC, ESSURE DEVICE NOTED TO HAVE PLASTIC-APPEARING SHEATH OVER THE INTRAUTERINE PORTION OF THE IMPLANT. THE DEVICE WAS ORIGINALLY INSERTED ON (B)(6) 2014. THE PATIENT HAD STARTED TO REPORT PAIN SINCE THE IMPLANT'S INTRODUCTION LEADING TO TODAY'S SURGICAL VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559619 ESSURE PERMANENT BIRTH CONTROL HHS BAYER HEALTHCARE LLC ESS305 B53652

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention