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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 (1802); Hair Loss (1877); Miscarriage (1962); Pain (1994); Rupture (2208)
Event Date 02/12/2009
Event Type  Death  
Event Description
(b)(4). Piercing pain in both sides. Miscarriage 3 years later. Hair loss, bloating, horrible pain, painful intercourse, another miscarriage and ruptured fallopian tube. Removal of both fallopian tubes.
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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key4960091
MDR Text Key17327287
Report NumberMW5044965
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 06/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2015
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: 08/03/2015 Patient Sequence Number: 1