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

Catalog Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Reaction (1733); Headache (1880); Pyrosis/Heartburn (1883); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Numbness (2415); Abdominal Distention (2601)

Event Date 12/30/2010

Event Type  Injury  

Event Description

On (b)(6) 2017 i received the essure.In (b)(6) 2010, i started having thyroid issues and was diagnosed with hashimoto disease.After that i had to have my gallbladder removed.Since then i have had severe inflammation, numbness and pain in my extremities, bloating pelvic pain, massive bleeding, heartburn, fog memory, and migraines.I have been placed on several medications with no response.I was diagnosed with lupus, ra, and fibromyalgia.But all blood work was negative.I also had an endometrial ablation.I finally had a hysterectomy on (b)(6) 2018.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7869086
• MDR Text Key: 120119247
• Report Number: MW5079738
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ESS305
• Device Lot Number: 740659
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 96