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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCEPTUS ESSURE

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CONCEPTUS ESSURE Back to Search Results
Event Date 12/30/2011
Event Type  Death  
Event Description

I had essure implanted because my dr said it was 100% effective with no known side effects. One year and a half i got pregnant and the pregnancy was ectopic. I went to the emergency room because my life was at risk. I now suffer heavy bleeding, migraines, bloating, nausea, mood swings, hair loss. I just found out that my right coil is in place and the left coil is not. Now at (b)(6) i'm facing hysterectomy. It's been a nightmare.

 
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
CONCEPTUS
MDR Report Key3471501
Report NumberMW5032825
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Source Type Invalid data
Reporter Occupation Patient
Type of Report Initial
Report Date 10/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No
Was Device Evaluated By Manufacturer? No Answer Provided
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/15/2013 Patient Sequence Number: 1
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