BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16887619 · Received May 5, 2023

    Report

    Report Number
    MW5117332
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    November 6, 2016
    Report Date
    April 30, 2023
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS NOT PROPERLY NOTIFIED OR INFORMED AS WELL AS CUT OFF FROM MEDICAL CARE TREATMENT, AS WELL AS ANY CHECKUPS SHORTLY AFTER GETTING THE DEVICE. I WAS NOT PROPERLY INFORMED ABOUT THE RISK AS WELL AS WAS TOLD IT WAS REVERSIBLE, AND I WOULDN'T HAVE TO HAVE A HYSTERECTOMY; I REPORTED PROBLEMS WITHIN WEEKS AFTER GETTING THE DEVICE PROCEDURE DONE AND WAS DISREGARDED, AND KNOWINGLY IGNORED EVEN TO DATE WITH MEDICAID HAS CAUSED ME OVER 75 MISCARRIAGES, AS WELL AS MULTIPLE LIFE THREATENING MEDICAL CONDITIONS AND PROBLEMS. I HAVE LOGGED TWO DIFFERENT MEDICAL BOARD COMPLAINTS, ONE ON DOCTOR WHO DID THE PROCEDURE AS WELL AS THE PRIMARY CARE DOCTOR. I'VE HAD LISTED FOR OVER A YEAR AND NOT ONE APPOINTMENT DEFINITELY NOT FROM LACK OF TRYING. I'VE CONTACTED EVERYONE REGARDING THIS. I WILL NOT BE SILENCED THIS DEVICE CUTS THROUGH THE EGG AFTER IT'S ALREADY CONCEIVED WITH THAT ALREADY HAS A SOUL DEATH WAS NEVER MEANT TO BE PUT IN THE HANDS OF ARE DOCTORS THAT ARE GIFTS FROM GOD TO GIVE LIFE PROLONG, LIFE SAVE LIFES AND MAKE ARE PASSING EASIER THIS IS A ABSOLUTE OUTRAGE THIS IS NOT EVEN A SPRINKLE OF DOCUMENTATION AND FACTUAL STATEMENTS AND INFORMATION REGARDING THIS LET ME HEAL THIS NATION AS GOD INTENDED INTENDS AND IS GOD WILL PLEASE AND THANK YOU. CONTACT TED (B)(6) ABBOTT. THE UNITED STATES PRESIDENT ETC. GOD BLESS. ENSURE AS WELL IT'S THE SAME DOES THE SAME THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687295 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER HEALTHCARE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Life Threatening| H| S| R