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

Device Problem Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Nausea (1970); Perforation (2001); Weakness (2145); Heavier Menses (2666)

Event Date 09/14/2018

Event Type  Injury  

Event Description

I went to the (b)(6) emergency room for severe abdominal pain, nausea, weakness etc.(b)(6) 2018.After radiology results i required emergency surgery due to essure puncturing my left fallopian tube.Causing a hemorrhagic blood filled cyst on my left ovary and my appendix react up.I had to get both fallopian tubes, left ovary and appendix taken out.I have been an emotional wreck since the essure was placed in 2012.I have excessive bleeding, during periods.Long periods, emotional and physical problems, pain during intercourse prior to surgery.I have been abstinent since emergency surgery due to emotional and physical fear from surgery.I hate that this device was created and wish i never used it.It has ruined my life.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: 8842249
• MDR Text Key: 152954498
• Report Number: MW5088474
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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: 77