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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 01/15/2007
Event Type  Injury  
Event Description

(b)(4) beginning post implant of essure i developed reactions, allergies to medications, foods, chemicals, sunscreen, bug repellent. Requires epipen to be on hand. Gi problems, can't digest red meat. Ibs-d, fatigue, depression, vit d deficiency, b12 deficiency, joint inflammation and pain, extremely painful back, stomach swelling /extension that appears like pregnancy, shooting nerve pain in foot, painful sex, painful periods, heavy periods with passing clots, blurred vision, dizziness/unsteady mess, foggy head, memory loss, metal taste in mouth, intermittent rash and hives, thinning hair. Had surgery on (b)(6) 2017. Upon waking up from surgery/ 24 hours, the following disappeared: metal taste in mouth, joint inflammation and pain, back pain, fatigue, foggy /unclear head, memory/word recollection, dizziness. Within 4 days i began seeing improvement: in gi system, visible difference in my stomach swelling.

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Brand NameESSURE
Manufacturer (Section D)
MDR Report Key5397058
Report NumberMW5059744
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2016
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: 01/28/2016 Patient Sequence Number: 1