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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 Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Patient Problems Death (1802); Ectopic Pregnancy (1819); Headache (1880); Menstrual Irregularities (1959); Vomiting (2144); Dizziness (2194); Pregnancy (3193)
Event Date 01/04/2010
Event Type  Death  
Event Description
(b)(4). I had the essure device placed in (b)(6) 2007. I had the hsg done 8 weeks later and it confirmed that both fallopian tubes were occluded. Afterwards my periods became irregular. I was told by my doctor that they were irregular because of my weight and i was diagnosed with pre-diabetes. I was told to lose weight and then my cycle would regulate itself. In (b)(6) of 2010 i suffered a dizzy spell, with vomiting and headaches. Upon being admitted to the er i was diagnosed with vertigo. During that visit they wanted to do an mri but i refused it because none of the doctors or nurses could explain how the electromagnetic field would effect the essure coils. (b)(6) of 2011 i found out i was pregnant with my third child. The doctor that i was seeing was not trained to perform the essure procedure so she went to a conference and spoke with some essure sales representatives. My son died as a result of her lack of knowledge at (b)(6). After the pregnancy my periods continued to be irregular. The would last about 30-35 days every other month. A new doctor then diagnosed me with uterine polyps and a surgery was scheduled to remove them. During the surgery it was found that the essure coils had migrated out of my fallopian tubes and were now lodged in my uterus. The visible coils were removed, there is still one of the coils left lodged in the left wall of my uterus. (b)(6) of 2014 i was admitted to the er and diagnosed with and ectopic pregnancy. Surgery was performed and half of my left ovary was removed, both fallopian tubes remained in tack and open. (b)(6) of 2015 i became pregnant again. I am currently (b)(6).
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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key5107430
MDR Text Key26883062
Report NumberMW5056532
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 09/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2015
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: 09/28/2015 Patient Sequence Number: 1