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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE

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BAYER ESSURE Back to Search Results
Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
Patient Problems Death, Intrauterine Fetal (1855); Fetal Distress (1856); Therapeutic Response, Decreased (2271); Fibrosis (3167); Pregnancy (3193)
Event Date 08/01/2009
Event Type  Death  
Event Description
(b)(4). I received this email today. "good afternoon, found the email you on the internet after much searching on the essure problems. And after so much research, since few sites talking about the evils that cause this device, i am sure that he was the cause of one of the biggest losses for my family! it all started in (b)(6) 2014, when my aunt performed the procedure with essure. In (b)(6), he returned to the hospital for examinations and see if he was all right! the doctor who did the procedure and analyzed the examinations of my aunt, secured its ligation and was clear in saying that my aunt never get pregnant! in (b)(6) this year, she discovered she was pregnant two months! it led all other medical examinations and it was found that one of her fallopian tubes had not been completely blocked! and your doctor was negligent in not paying attention to this detail and give you high! we are (b)(6) and here the method is new, and during her pregnancy no doctor informed us that the device could be harmful to the baby! everything went wonderfully well, your last visit was on (b)(6) and everything was fine with the mother and the baby. Our little one was perfect, with (b)(6) weeks! we waited looking forward to your arrival and all was ready! on (b)(6), upon waking, my aunt felt a small loss of liquid! i had no pain and no more evil! he waited a bit, had been through this 22 years ago, he knew he had time. Before long, she decided to go to the hospital because the liquid does not stop! there was promptly answered. They made an ultrasound and saw that the baby girl was suffering because he had done a little stool and failed to listen to your heart! they made an emergency cesarean section. Already removed the drinks without the womb of life! they tried to resuscitate her, but the effort was in vain. Clinical examinations revealed that our little one was already dead more than 24 hours! the mother's placenta had not taken off, the umbilical cord had not hanged him, heart and lung were ok! the mother had no diabetes or high blood pressure, or any type of infection that could have caused the death of the baby! we were ungrounded, with no drinks and no explanation! but the doctor who did the cesarean, left us with a cruel doubt! she examined the tubes of my aunt, in front of my uncle and found neither devices nor felt the fibrosis that he would cause with time! we are concerned where he is! we did not have the courage to ask autopsy of the baby! it was one 'judiaandccedil;andatilde;o' what had happened to her! it was not fair to that princess, be open only for an answer! if he's with her, ever been to! unfortunately nothing will bring her back to us! but if you're not in it, still on my aunt, floating in it and can cause you more harm! the placenta was sent for examination, for those who know it, we find an answer to this tragedy! my aunt also do further tests to look for the device inside it! nothing will bring our little back! but we need an answer to at least try to ease our pain and our suffering! and yesterday, while in the hospital, my aunt learned of another case in our city, where a pregnant lady also undergone the essure procedure! we hope, heart, find an answer to it all! and thus be able to further raise our flag against the essure! i came through this because it does not want to make this public story yet! it still hurts quite me! imagine for parents! just i wanted to vent and tell this sad story so that one day no one has to go through it! thank you, for now! sincerely, (b)(6)!'.
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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key5074466
MDR Text Key25678089
Report NumberMW5056099
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/07/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2015
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/14/2015 Patient Sequence Number: 1