BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3802966 · Received May 6, 2014

    Report

    Report Number
    2951250-2014-00137
    Event Type
    Other
    Date Received
    May 6, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED FAILED RIGHT SIDE, DEVICE TIP BENT/BROKE, AND COMPLICATION OF DEVICE INSERTION. NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS, CONCURRENT CONDITION AND CONCOMITANT MEDICATION RECEIVED. ON (B)(6), 2013 THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, LOT NUMBER A95862. ON (B)(6) 2013 THE PATIENT EXPERIENCED FAILED RIGHT SIDE, DEVICE TIP BENT/BROKE, AND COMPLICATION OF DEVICE INSERTION. PATIENT FOLLOWED WITH A TUBAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270047 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305
    270048 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention