MAUDE Adverse Event Report: BAYER HEALTHCARE ESSURE

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

Patient Problems Autoimmune Disorder (1732); Pain (1994); Skin Irritation (2076); Sensitivity of Teeth (2427); Abdominal Distention (2601)

Event Date 07/15/2017

Event Type  Injury  

Event Description

My obgyn inserted 3 coils into my fallopian tubes 2 on one side and 1 on the other.Essure caused me to develop an autoimmune disease, have dental problems, bloating, and constant pain.I had a hysterectomy to receive the pain.I am, now left with an autoimmune disorder that recently caused a benign tumor to develop on my leg, and regularly gives me eczema.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE
• MDR Report Key: 7714283
• MDR Text Key: 114999725
• Report Number: MW5078548
• Device Sequence Number: 3
• 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: 07/20/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 35 YR
• Patient Weight: 100