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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 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 NameESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4949864
MDR Text Key6633441
Report NumberMW5044880
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 01/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2015
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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