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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 Type  Death  
Event Description

I had the essure device installed and became pregnant afterwards. The baby died because of the prior procedures, i had to have 4 surgeries and a hysterectomy. I had depression and felt like a year of my life was lived in a fog afterwards.

 
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
BAYER
MDR Report Key5147868
Report NumberMW5056924
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Reporter Occupation Patient
Report Date 10/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2015
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 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: 10/07/2015 Patient Sequence Number: 1
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