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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 Name
Type of Device
Manufacturer (Section D)
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
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 Health Professional
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other;
Patient Age29 YR
Patient Weight99