MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Reaction (2414); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Date 09/14/2012

Event Type  Injury  

Event Description

I had the essure procedure done.I was supposed to be under for less than an hour and it turned out to be six to eight.My doctor had let one go and now i have a coil floating inside me.The other two were apparently properly placed.I was told they were made from the same material as a heart stent.Within two days i went to the emergency room as i was in horrible pain.My body was rejecting them and i had an adverse reaction.They discharged me after saying the pain would get better and they gave me pain killers.I believe i had blood in my urine as well, which went away on its own.My periods have been very heavy and painful since this and i have had chronic fatigue and brain fog with intermittent headaches.I also had lyme disease within the next year and have been attributing these symptoms to this since then.It was not until the news last week that i learned there was nickel in the device.I cannot wear most jewelry due to a nickel sensitivity and i would not be surprised if this has been the primary cause since then.I am looking to have these removed as soon as i can find a doctor who has experience in this.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7439442
• MDR Text Key: 105937224
• Report Number: MW5076532
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 70