BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2771817 · Received September 28, 2012

    Report

    Report Number
    MW5027140
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CONCEPTUS INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ESSURE PERMANENT BIRTH CONTROL IMPLANTED WITH POSITIVE PREGNANCIES: SIX CASES IDENTIFIED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE ESSURE PERMANENT BIRTH CONTROL HHS CONCEPTUS INC. ESS 305 787226

    Patients

    Seq Age Sex Outcome Treatment
    1