MAUDE Adverse Event Report: BAYER ESSURE

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
• Report Number: MW5056924
• Device Sequence Number: 1
• Product Code: HHS
• Report Source: Voluntary
• Reporter Occupation: Patient
• 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: NO INFORMATION
• 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