MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Fatigue (1849); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Myalgia (2238); Arthralgia (2355); Heavier Menses (2666)

Event Type  Injury  

Event Description

I believe i had essure implanted in (b)(6) or (b)(6) 2011.Since that time, i have experienced wide spread joint and muscle pain, fatigue, headaches, arthritis, fibromyalgia, diabetes and hashimotos.I also have possible lupus and rheumatoid arthritis diagnosis pending.Gynecologically, i have begun having more painful, heavier and irregular periods.I am also experiencing sharp shooting pains around the locations of my fallopian tubes around the time of my period, especially on the right side.I occasionally have bleeding with sex and pain with deeply penetrating sex (with some bleeding).I am scheduled for removal of my uterus, cervix and fallopian tubes on (b)(6) 2018.I am hoping this will lead to a lessening of symptoms.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7868763
• MDR Text Key: 120189442
• Report Number: MW5079718
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/08/2018

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
• 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 Weight: 95