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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 02/12/2009
Event Type  Death  
Event Description

(b)(4). Piercing pain in both sides. Miscarriage 3 years later. Hair loss, bloating, horrible pain, painful intercourse, another miscarriage and ruptured fallopian tube. Removal of both fallopian tubes.

 
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Brand NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4960091
Report NumberMW5044965
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Source Type Invalid data
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
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: 08/03/2015 Patient Sequence Number: 1
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