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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Weight Changes (2607)

Event Date 05/07/2010

Event Type  Injury  

Event Description

I was told to get an essure implant so i wouldn't have any more children.After 7 years, i had to have a hysterectomy at the age of (b)(6).I was in a lot of pain.Horrible periods that lasted weeks at a time.My hair was falling out.I couldn't sleep at night.Severe lower abdominal pain, back pain, constant headaches, weight gain, complete loss of sex drive.I couldn't focus on something for a long period of time.I could barely remember what i had for dinner the night before.It was a horrible way of life.I almost went through a divorce because my husband couldn't understand what i was going through.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8636537
• MDR Text Key: 146200161
• Report Number: MW5086856
• 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: 05/20/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 119