BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCEPTUS

    MDR report key: 2903841 · Received December 28, 2012

    Report

    Report Number
    MW5028462
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2009, AFTER THE BIRTH OF MY THIRD CHILD, I OPTED TO HAVE THE ESSURE BIRTH CONTROL DEVICES IMPLANTED. MY OB/GYN PERFORMED THE PROCEDURE IN HIS OFFICE WITH NO ISSUES. I HAD THE CONFIRMATION TEST PERFORMED AT THE REQUIRED THREE MONTH MARK AND THE TEST SHOWED THAT BOTH TUBES WERE COMPLETELY BLOCKED AND BACK UP BIRTH CONTROL WAS DISCONTINUED. IN (B)(6) 2012 I MISSED A PERIOD AND TOOK A HOME PREGNANCY TEST. IT CAME BACK POSITIVE. GIVEN THAT I HAVE ESSURE, I WAITED A WEEK AND THEN TOOK A SECOND HOME PREGNANCY TEST. AFTER THAT ONE ALSO CAME BACK POSITIVE. I CONTACTED MY OB/GYN WHO PERFORMED A VAGINAL ULTRASOUND ON (B)(6) 2012 AND CONFIRMED THAT I WAS INDEED 8 WEEKS AND 6 DAYS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCEPTUS ESSURE HHS CONCEPTUS, INC. 628969

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR