BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3802961 · Received May 6, 2014

    Report

    Report Number
    2951250-2014-00146
    Date Received
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVE FROM A CONSUMER IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SLIGHT PAIN, CRAMPING, SLIGHT BLEEDING, AND ONE OF THE SPRINGS WAS NOT IN THE CORRECT PLACE, IT WAS UP AGAINST MY COLON. NO INFO GIVEN ON CONSUMER'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE CONSUMER RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6) 2013 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR CONTRACEPTION. THE REPORTED LOT NUMBERS WERE, 787227 AND 922605. ON (B)(6) 2013 IMMEDIATELY AFTER INSERTION THE CONSUMER EXPERIENCED SLIGHT PAIN, CRAMPING AND SLIGHT BLEEDING. SHE STATED WHEN SHE WAS BENDING OVER, SHE FELT LIKE A SPLINTER INSIDE HER ON RIGHT SIDE. ON UNSPECIFIED DATE HSG (HYSTEROSALPINGOGRAM) SHOWED ONE OF THE SPRINGS WAS UP AGAINST COLON, SHE DID NOT KNOW WHICH SIDE. ESSURE WAS REMOVED ON (B)(6) 2013 AND THAT TIME CLIPS WERE REPLACED ON BOTH TUBES, AS BIRTH CONTROL. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN EVENT AND ESSURE IS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269692 ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE HHS BAYER HEALTHCARE LLC ESS305 787227

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention