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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTH ESSURE

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BAYER HEALTH ESSURE Back to Search Results
Device Problem Extrusion (2934)
Patient Problems Death (1802); Perforation (2001)
Event Date 01/22/2015
Event Type  Death  
Event Description

Perforation of uterus during elective hysteroscopic tubal occlusion procedure with essure device.

 
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
BAYER HEALTH
MDR Report Key4684438
MDR Text Key5670510
Report NumberMW5042068
Device Sequence Number1
Product Code HHS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/07/2015 Patient Sequence Number: 1
Treatment
LIDOCAINE; PREMEDICATED WITH PERCOCET,
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