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

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

Patient Problems Abdominal Pain (1685); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Thyroid Problems (2102); Uterine Perforation (2121); Confusion/ Disorientation (2553)

Event Date 03/20/2015

Event Type  Injury  

Event Description

I had the essure place (b)(6) of 2015.After first try perforated my uterus.Since then have had to see many specialists to figure out what was wrong.First increase of migraines.Required preventative medication to help.Increase bleeding and pelvic pain.Appendectomy in (b)(6) of 2015.Surgeon found blood in abdomen not sure where the blood came from.Continued with pain.Had blisters and hives appear for no reason.Went to immunologists to see if they could figure where it was coming from.Unable to be determined.Bleeding and pain got worse.Started having gut issues had gallbladder removed.Went to gynecologist said i had pcos at (b)(6).Never had before and hormone labs were normal.Recommended hysterectomy to help with bleeding.Abdominal pain, pain with sex, pain shooting from back to front, heaving bleeding.Have had increased brain fog forgetting things i have done for years.Diagnosed with add the hashimotos due to elevated tpo antibodies being at 382.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: 9468001
• MDR Text Key: 171546354
• Report Number: MW5091660
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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; Other
• Patient Age: 34 YR
• Patient Weight: 100