MAUDE Adverse Event Report: BAYER HEALTH ESSURE

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.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTH
• MDR Report Key: 4684438
• MDR Text Key: 5670510
• Report Number: MW5042068
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• 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 Received: 04/07/2015
• 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 Sequence Number: 1
• Treatment: LIDOCAINE; PREMEDICATED WITH PERCOCET,
• Patient Outcome(s): Death
• Patient Age: 31 YR
• Patient Weight: 69