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MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE
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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.
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Submit an Adverse Event Report
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
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