MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Swelling (2091); Blurred Vision (2137); Anxiety (2328); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 12/10/2010

Event Type  Injury  

Event Description

In 2010, i received the essure birth control implant.Since that time, i have been diagnosed with gastroparesis.Eosinophilic colitis, carpel tunnel both hands - required surgery.Trigger thumb release both hands - required surgery.Ptsd, pelvic pain, shingles.I suffer from painful bloating and abdominal and facial swelling.I have overall body inflammation, referred to rheumatologist for high inflammatory presence in blood.Sexual dysfunction, headaches, blurry vision, chronic diarrhea, missed days of work.Inability to sit, lay, walk or stand for long distances.Foot and leg fatigue and pain.Limited social life due to illness.Unable to attend functions with my daughter due to pain and fatigue.Life plans for continued education on hold due to illnesses.Multiple short term disability claims in last four years.Brain fog, wordlessness, short term memory loss.Skin lesions, rosacea vitamin b and d deficiencies.Appetite loss.Weight gain, nausea.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7957111
• MDR Text Key: 123670651
• Report Number: MW5080483
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2018

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
• Device Model Number: ESS305
• Device Lot Number: 654842
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 113