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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Diarrhea (1811); Emotional Changes (1831); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144); Prolapse (2475); Abdominal Cramps (2543); No Code Available (3191)

Event Type  Injury  

Event Description

After essure placement my menstrual cycles have become more irregular ranging from duration of 2 days up to 12 and frequencies from 1 week to 10 months.I've had increased menstrual symptoms including pain, migraines, cramping, tenderness, mood swings, and pain, vomiting, diarrhea, and bleeding that now keep me in bed and prevent me from leaving the house.I have sexual dysfunction.Menorrhagia, dysmenorrhea, ovarian cysts, prolapsed uterus.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: 8624014
• MDR Text Key: 145682971
• Report Number: MW5086744
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Disability
• Patient Weight: 125