BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4002615 · Received August 11, 2014

    Report

    Report Number
    MW5037701
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ESSURE DEVICE WAS DEPLOYED INTO FALLOPIAN TUBE. UPON REMOVAL OF THE INSERTION DEVICE, THE COIL WAS NOTED TO STILL BE PRESENT ON THE INSERTER, HAVING PULLED OUT OF THE FALLOPIAN TUBE INTACT. DIAGNOSIS OR REASON FOR USE: ELECTIVE STERILIZATION. MANUFACTURER NAME, CITY AND STATE: AR-MED LTD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475407 ESSURE PERMANENT BIRTH CONTROL HHS ESS305 A63347

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention