BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3820086 · Received May 14, 2014

    Report

    Report Number
    2951250-2014-00153
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 7, 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
    PHYSICIAN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CAE REPORT RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN (B)(6) ON (B)(6) 2014 WHICH REFERS TO A FEMALE PT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND IT WAS IMPOSSIBLE TO RELEASE THE DEVICE: BROKEN CATHETER AND IMPOSSIBLE WITHDRAWAL AND THE DELIVERY WAS NOT BILATERAL. NO INFO GIVEN ON PT'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATION. ON (B)(6) 2014 THE PT HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION, LOT NUMBER 50750351. THE REPORTER STATED THAT, ALTHOUGH CONDITIONS OF THE PLACEMENT WERE EXCELLENT, DURING DEVICE PLACEMENT THE COILS DEVICE WAS NOT RELEASED AND IT WAS IMPOSSIBLE TO REMOVE THE CATHETER (BROKEN CATHETER AND IMPOSSIBLE WITHDRAWAL). THE DELIVERY WAS NOT BILATERAL AND A CELIOSCOPY TO REMOVE DEVICE WAS REQUIRED. THE DEVICE WAS KEPT IN THE HOSPITAL. THE CRITERION OF SERIOUSNESS WAS BY THE REPORTER AS A SERIOUS RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288918 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 50750351
    288919 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 50750351

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other