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

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Headache (1880); Patient Problem/Medical Problem (2688)

Event Date 02/21/2017

Event Type  Injury  

Event Description

I had essure in 2006.Soon after, migraines began.In 2017, i had to have a hysterectomy.In 2018 i was diagnosed with an auto immune disorder.I'm unable to work.Ssa denied benefits.I'm devastated.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7776670
• MDR Text Key: 117012358
• Report Number: MW5079067
• 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: 08/09/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 73