BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3802967 · Received May 6, 2014

    Report

    Report Number
    2951250-2014-00141
    Event Type
    Other
    Date Received
    May 6, 2014
    Date of Event
    August 1, 2013
    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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# MW5034821) IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SHARP SHOOTING PAIN IN MY OVARY AREA, BROKE OUT IN A CHRONIC RASH, GAINED 10 LBS, AND CHRONIC HIP AND KNEES ACHES/PAINS. 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. IMMEDIATELY AFTER ESSURE INSERTION, PT STARTED TO EXPERIENCE SHARP, SHOOTING PAIN IN OVARY AREA. SHE BROKE OUT IN CHRONIC RASH, GAINED 10 LBS WITHOUT CHARGING DIET AND EVEN AFTER STARTING YOGA 5 DAYS A WEEK. SHE HAD CHRONIC HIP AND KNEE ACHES/PAIN AND KEPT FEELING WORSE AND WORSE. ESSURE WAS DISCONTINUED ON (B)(6) 2014. CONSUMER DID NOT RESPOND TO F/U ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271160 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention