MAUDE Adverse Event Report: BAYER ESSURE

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.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5117163
• Report Number: MW5056665
• Device Sequence Number: 1
• Product Code: HHS
• 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 Received: 09/25/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• 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