MAUDE Adverse Event Report: BAYER ESSURE

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Cramp(s) (2193); Heavier Menses (2666)

Event Date 11/17/2010

Event Type  Injury  

Event Description

(b)(4).Cramping immediately after implantation.Over the course of the five years i had this device in my body, i suffered from severe migraines, extremely heavy menstrual cycles, sharp/stabbing lower abdominal pain, extreme fatigue, was diagnosed with diabetes type 2 and emotional problems.Mid year 2015, i began experiencing restless leg syndrome and joint pain.The joint pain was so bad, i had difficulty performing daily tasks.I finally had to have a hysterectomy to get the essure device out of me.I still have some of the side affects but most are beginning to fade away.I had my hysterectomy (b)(6) 2015, everything but ovaries was removed.My tubes where the essure device was implanted were covered with cysts.I had a fibroid tumor on my uterus.I had endometriosis on the outside of my uterus.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5359276
• MDR Text Key: 35608530
• Report Number: MW5059197
• 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: 01/10/2016

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 37.000 YR