BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3820087 · Received May 14, 2014

    Report

    Report Number
    2951250-2014-00152
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 8, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT REC'D FROM A REGULATORY AUTHORITY (CASE# (B)(4)) IN (B)(6) ON (B)(6) 2014 WHICH REFERS TO A (B)(6) OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MIGRATION OF ONE DEVICE IN THE ABDOMINAL CAVITY AND PART OF THE SPRING WAS MISSING ON THIS EXPLANTED DEVICE. NO INFO WAS GIVEN ON THE PATIENT'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATION. ON (B)(6) 2013 THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED; THE LOT NUMBER B26271 WAS PROVIDED. SHE PRESENTED WITH ABDOMINAL PAIN AND ON (B)(6) 2014, THE RIGHT DEVICE WAS FOUND TO HAVE MIGRATED INTO THE ABDOMINAL CAVITY (IT WAS PLACED ON THE SIGMOID OPPOSITE TO THE UTERUS - A RISK OF RECTUM PERFORATION WAS REPORTED BY THE SURGEON). BOTH DEVICES WERE REMOVED, THE ABDOMINAL CAVITY WAS EXTENSIVELY WASHED AND A BILATERAL SALPINGECTOMY WAS PERFORMED. THE SURGEON NOTICED THAT THERE WAS A PART OF THE COIL MISSING IN THE EXPLANTED DEVICE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AND SHE HAD NO COMPLICATIONS POSTOPERATIVELY. THE REPORTER'S CAUSALITY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288888 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B26271
    288889 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B26271

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other