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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 06/08/2015
Event Type  Death  
Event Description

(b)(4). Became pregnant while relying on essure, complications from the device led to the death of the infant girl.

 
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Brand NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4906242
Report NumberMW5043972
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Source Type Invalid data
Reporter Occupation Patient
Type of Report Initial
Report Date 06/07/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2015
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: 07/10/2015 Patient Sequence Number: 1
Treatment
ESSURE
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