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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
Event Date 01/01/2012
Event Type  Injury  
Event Description

(b)(4). After essure i had new: pelvic pain. Severe periods with huge clots. Body aches. Hair loss. Brain fog. Depression. Stabbing pain near my left tube. Weight gain. Belly/bloating. Constipation. Irritated skin. And it all ended with a full hysterectomy at (b)(6) yrs old.

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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key5393796
Report NumberMW5059633
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 01/27/2016 Patient Sequence Number: 1