BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3780989 · Received April 17, 2014

    Report

    Report Number
    2951250-2014-00113
    Event Type
    Other
    Date Received
    April 17, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN THE UNITED STATES ON (B)(6) 2014 WITH REQUEST FOR REPLACEMENT OF ONE DEVICE. THE REPORT REFERS TO A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ESSURE BROKE OFF AFTER INSERTION AND HAD TO BE REMOVED. NO INFORMATION WAS GIVEN ON PATIENT'S HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITIONS. ON (B)(6) 2014, THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER B63564, INSERTED. ON (B)(6) 2014, ESSURE BROKE OFF AFTER INSERTION AND HAD TO BE REMOVED, ANOTHER WAS INSERTED SUCCESSFULLY. THE PATIENT HAD NO INJURY. REPORTER DID NOT ASSESS DEVICE-EVENT RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236317 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B63564
    236318 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B63564

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female