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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 Migration or Expulsion of Device (1395)
Patient Problems Autoimmune Reaction (1733); Diarrhea (1811); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Sjogren's Syndrome (2073); Skin Irritation (2076); Weakness (2145); Twitching (2172); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Shaking/Tremors (2515); Cognitive Changes (2551); Constipation (3274)
Event Date 07/11/2019
Event Type  Injury  
Event Description
I had essure coils placed in (b)(6) 2011.They were placed correctly.Health issues started that year including chronic generalized muscle and joint pain, hip pain, shoulder pain, wrist pain, severe chronic fatigue, gi problems, indigestion, diarrhea, constipation, autoimmune issues, sjogren's syndrome, low ig levels, persistent pelvic pain, random allergies, sinus issues, rashes, boils, various chronic/recurring weakness, dizziness, neurological issues like brain fog, memory problems, twitching and trembling, severe anxiety.Had a total hysterectomy salpingectomy to remove devices.The left device had migrated, was totally in the tube and was pressing on my ovary.Fda safety report id# (b)(4).
 
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER HEALTHCARE LLC
MDR Report Key8793687
MDR Text Key151337084
Report NumberMW5088145
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 07/12/2019
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? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age44 YR
Patient Weight57
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