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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 Problem Malposition of Device (2616)
Patient Problems Failure of Implant (1924); Menstrual Irregularities (1959); Miscarriage (1962); Nausea (1970); Cramp(s) (2193); Weight Changes (2607)
Event Date 09/21/2012
Event Type  Death  
Event Description
I was implanted with the essure device (b)(6) 2012. I was not scheduled for the follow up dye test until the following (b)(6) 2013, after i suffered a miscarriage. There was a scheduling conflict with radiology and i was never rescheduled for the dye test. I suffered another miscarriage in (b)(6) 2014 and had to have an emergency dnc done. I followed up with the doctor who implanted that essure device and he finally scheduled my dye test for (b)(6) 2014. At that time i was notified that only one side of my fallopian tubes was closed and that i still stood a chance of getting pregnant. I have debilitating cramps and am nauseous more times out of the month than not and have not had a regular cycle since 2012. I have gained in the upwards of (b)(6) pounds that i am unable to lose even with diet and exercise.
 
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
BAYER
MDR Report Key5117163
MDR Text Key27303511
Report NumberMW5056665
Device Sequence Number1
Product Code HHS
Reporter Country CodeUS
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 Received09/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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: 09/25/2015 Patient Sequence Number: 1
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