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MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE
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Device Problem
Therapeutic or Diagnostic Output Failure (3023)
Patient Problems
Emotional Changes (1831); Hemorrhage/Bleeding (1888); Miscarriage (1962); Pain (1994); Depression (2361)
Event Date
04/05/2015
Event Type
Death
Event Description
(b)(4). Had a miscarriage. Lot of pain and blood. I had a sonogram, ct scan , mri, blood work. I am in shock and very depressed. I didn't even know i was pregnant. Having hysterectomy (b)(6) 2015 due too essure device failure.
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Brand Name
ESSURE
Manufacturer
(Section D)
BAYER
MDR Report Key
4949864
MDR Text Key
6633441
Report Number
MW5044880
Device Sequence Number
1
Product Code
HHS
Combination Product (y/n)
N
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Source Type
Invalid Data
Reporter Occupation
Patient
Type of Report
Initial
Report Date
01/17/2015
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
07/29/2015
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
Other
Is the Reporter a Health Professional?
No
Was Device Evaluated by Manufacturer?
No Answer Provided
Type of Device Usage
Invalid Data
Patient Treatment Data
Date Received: 07/29/2015 Patient Sequence Number: 1
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