MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Depression (2361)

Event Type  Death  

Event Description

I had the essure device installed and became pregnant afterwards. The baby died because of the prior procedures, i had to have 4 surgeries and a hysterectomy. I had depression and felt like a year of my life was lived in a fog afterwards.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5147868
• MDR Text Key: 28315760
• Report Number: MW5056924
• 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: Patient
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/07/2015 Patient Sequence Number: 1