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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Dizziness (2194); Abdominal Cramps (2543); Ambulation Difficulties (2544); Cognitive Changes (2551); Heavier Menses (2666)

Event Date 10/06/2018

Event Type  Injury  

Event Description

I had essure in (b)(6) 2015.Since then i had 8 sinus infections 1 year from not having any prior.I had to have sinus surgery.I went from no allergies to severe seasonal allergies.I have been increasingly fatigue since essure put in.Now i can barely stay awake through full day at work.I started having migraines and headaches a year ago previously never had.No medication prescribed helped.About a year ago, i started having dizzy spells.They have gotten to point where i cannot walk straight when they hit, and are lasting for days.Periods are heavier than they were in past.Previously i did not get cramps when i was on period, now i get very painful cramps.I have been having brain fog so bad that i loose memory of some of the day.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC. ; 100 bayer blvd; whippany NJ 07981
• MDR Report Key: 7956177
• MDR Text Key: 123670779
• Report Number: MW5080457
• 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: 10/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Age: 33 YR
• Patient Weight: 72