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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Autoimmune Disorder (1732); Neuropathy (1983); Pain (1994); Burning Sensation (2146); No Code Available (3191); Cancer (3262)
Event Date 01/01/2013
Event Type  Injury  
Event Description
I had the essure procedure done in (b)(6) 2012.A few months later, i started experiencing pain in my mid-back that felt like i had over-worked my muscles.That has gotten steadily worse since that time.Then in (b)(6)2015, i started to have severe burning in my hands and lower part of my legs.I went to numerous neurologists and finally found out that i had small fiber neuropathy caused by autoimmune problems.About a year later, the pain in my back started to move to many other parts of my body.I was diagnosed with stiff person's syndrome, another autoimmune disease.In 2017 i was diagnosed with myeloma, a type of blood cancer.I have to take many medications to manage my symptoms.
 
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER HEALTHCARE, LLC
MDR Report Key7714334
MDR Text Key114975606
Report NumberMW5078551
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/23/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age40 YR
Patient Weight52
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