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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
Event Date 11/17/2010
Event Type  Injury  
Event Description

(b)(4). Cramping immediately after implantation. Over the course of the five years i had this device in my body, i suffered from severe migraines, extremely heavy menstrual cycles, sharp/stabbing lower abdominal pain, extreme fatigue, was diagnosed with diabetes type 2 and emotional problems. Mid year 2015, i began experiencing restless leg syndrome and joint pain. The joint pain was so bad, i had difficulty performing daily tasks. I finally had to have a hysterectomy to get the essure device out of me. I still have some of the side affects but most are beginning to fade away. I had my hysterectomy (b)(6) 2015, everything but ovaries was removed. My tubes where the essure device was implanted were covered with cysts. I had a fibroid tumor on my uterus. I had endometriosis on the outside of my uterus.

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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key5359276
Report NumberMW5059197
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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

Date Received: 01/11/2016 Patient Sequence Number: 1