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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Arthralgia (2355); Confusion/ Disorientation (2553)

Event Date 01/05/2012

Event Type  Injury  

Event Description

In (b)(6) 2012, i made the decision to have a uterine ablation (novasure) and essure done at the same time ¿ for the purpose of permanent birth control.Within a couple years, i had several very troubling side effects that i¿ve narrowed down to the essure coils.These include intense pain during intercourse, multiple and painful periods each month (i was regular prior to essure), brain 'fog¿/forgetfulness and horrible joint pain.In 2013 i saw an obgyn to determine why there was so much pain with intercourse.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 8386138
• MDR Text Key: 137793605
• Report Number: MW5084583
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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: 42 YR
• Patient Weight: 82