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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Emotional Changes (1831); Pain (1994)
Event Date 01/29/2015
Event Type  Death  
Event Description

(b)(4). Suicide, death. Pain and problems from essure.

 
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Brand NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4660870
MDR Text Key5681441
Report NumberMW5041820
Device Sequence Number1
Product Code HHS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
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 Received04/06/2015
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: 04/06/2015 Patient Sequence Number: 1
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