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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Death, Intrauterine Fetal (1855); Pregnancy (3193)
Event Date 06/08/2015
Event Type  Death  
Event Description
(b)(4). Became pregnant while relying on essure, complications from the device led to the death of the infant girl.
 
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Brand NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4906242
MDR Text Key6830971
Report NumberMW5043972
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
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
Date FDA Received07/10/2015
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: 07/10/2015 Patient Sequence Number: 1
Treatment
ESSURE
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