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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
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
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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