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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 Problems Device Dislodged or Dislocated (2923); Extrusion (2934); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Death, Intrauterine Fetal (1855); Hemorrhage/Bleeding (1888); Rupture (2208); Pregnancy (3193)
Event Date 06/08/2015
Event Type  Death  
Event Description
(b)(4). I delivered a (b)(6) stillborn baby on (b)(6) 2015. I had the essure placed in (b)(6) 2013. The had an hsg that showed the essure did not properly form the scar tissue and my tube was still open. I started taking depot shots. I had no clue i was pregnant, until a few days before, which was on a weekend, and was going to call the ob on (b)(6). (b)(6) evening, i started bleeding profusely, went to the er, and delivered a (b)(6) who was still born. As of (b)(6) evening she was very active. My ob told me that the essure was dislodged and was sticking out enough in my abdominal space that it ruptured my placenta, which led to fetal demise.
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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key4906077
MDR Text Key6029906
Report NumberMW5043953
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 06/09/2015
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