BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD)

    MDR report key: 20723434 · Received November 18, 2024

    Report

    Report Number
    MW5162623
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    September 25, 2013
    Report Date
    April 22, 2025
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT NUMBER MW5162623 ON APRIL11TH, 2025: CHRONIC PAIN, SUSPECTED MIGRATION, AND FRAGMENTED ESSURE MATERIAL STILL VISIBLE ON IMAGING AS OF.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 4/22/2025 FOR REPORT MW5162623. AS MENTIONED IN MY ORIGINAL REPORT (B)(4), I DID NOT RECEIVE THE REQUIRED HSG CONFIRMATION TEST, YET MY STERILIZATION STATUS WAS MARKED 'CONFIRMED' IN MY RECORDS UNDER ICD CODE V26.51. THIS CONTRADICTS PROPER MEDICAL PROTOCOL AND RAISES SERIOUS CONCERNS ABOUT THE ACCURACY AND ETHICS OF THE DOCUMENTATION SUBMITTED BY MY PROVIDERS.

    Description of Event or Problem · 0

    I NEED HELP! MY DOCTORS OVER MY ESSURE PLACEMENT AND NEEDING A FULL HYSTERECTOMY ARE I DON'T KNOW HOW ELSE TO PUT IT BUT SHADY AND TO ME UNETHICAL. SO MUCH COVER UP BY MY DOCTORS AND I'M STILL HAVING A SUPER HARD TIME GETTING MY HEALTH BACK. I HAD A CLAIM, BUT LAWYER DID IT UNDER SOME SERIOUSNESS MISCONDUCT AND BREACH OF CONTRACT, I'M OVER THAT. THEY GOT ALL THE MONEY AND LIED TO ME ON SO MANY LEVELS! I CAN'T GET ALL INFORMATION ABOUT MY ESSURE, AND I CAN'T GET ALL MY INFORMATION FROM THE DOCTOR WHO WORKS IN THE SAME CLINIC WHO HAD TO GIVE ME A FULL HYSTERECTOMY. I WANTED A TUBAL LITIGATION BUT GOT CONVINCED TO USE ESSURE INSTEAD. MY DOCTOR GOT PAID BY THE SAME COMPANY DURING THE SAME TIME FRAME AND BECAUSE OF THE MALPRACTICE AND COVER-UP, I CAN'T GET MY BODY OR ANYONE TO SERIOUSLY TAKE A LOOK AT WHAT'S GOING ON WITH ME. HOW IS IT FAIR TO NEVER GET TOLD BY MY DR WHO HAS BEEN SUED FOR THIS PROCEDURE, AND OHP TAKE CLOSE TO (B)(6) TO COVER THEIR MISTAKE?! I AM STILL SUFFERING HUGELY OVER THIS PRODUCT, I KNOW I HAVE FRAGMENTS LEFT INSIDE MY BODY YOU CAN TELL BY THE REPORTS. THERE ARE SO MANY REPORTS THAT I CAN'T GET A HOLD OF AND I THINK IT'S UNFAIR. COULD YOU PLEASE LEAD ME IN THE RIGHT DIRECTION ON FIGURING OUT WHAT EXACTLY IS GOING ON WITH MY ESSURE PRODUCT. MY TUBES CERVIX UTERUS WAS PUT INSIDE A ZINC JAR AND SENT SOMEWHERE? I WANT TO KNOW HOW TO FIX ME, MY TEETH, MY AUTOIMMUNE DISEASES, ARE OFF THE CHAIN. PLEASE HELP ME FIND MY INFORMATION FROM MY DOCTOR WHO HAS BEHIND MY BACK WITHOUT MY KNOWLEDGE HAS BEEN DEALING WITH MY RECENT HOSPITAL ENCOUNTERS. ANY AND ALL INFORMATION WOULD BE SO AWESOME. I APPRECIATE YOUR TIME. GOD BLESS. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336298 ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD) TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER HEALTHCARE, LLC. ESS305 B42242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown