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MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE
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Device Problem
Device Operates Differently Than Expected (2913)
Patient Problems
Death (1802); Emotional Changes (1831); Pain (1994)
Event Date
01/29/2015
Event Type
Death
Event Description
(b)(4).Suicide, death.Pain and problems from essure.
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Brand Name
ESSURE
Manufacturer
(Section D)
BAYER
MDR Report Key
4660870
MDR Text Key
5681441
Report Number
MW5041820
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
06/07/2013
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
Other
Is the Reporter a Health Professional?
No
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
04/06/2015
Patient Sequence Number
1
Patient Outcome(s)
Death;
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