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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 04/05/2015
Event Type  Death  
Event Description

(b)(4). Had a miscarriage. Lot of pain and blood. I had a sonogram, ct scan , mri, blood work. I am in shock and very depressed. I didn't even know i was pregnant. Having hysterectomy (b)(6) 2015 due too essure device failure.

 
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Brand NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4949864
Report NumberMW5044880
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Source Type Invalid data
Reporter Occupation Patient
Type of Report Initial
Report Date 01/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2015
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: 07/29/2015 Patient Sequence Number: 1
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