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

Catalog Number ESS305

Device Problem Break (1069)

Patient Problems Abdominal Pain (1685); Bruise/Contusion (1754); Fatigue (1849); Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 07/26/2013

Event Type  Injury  

Event Description

I was implanted with a device known as essure on (b)(6) 2013.My lot number is a96181, my reference number is (b)(4).During the implantation process, one of the essure coils broke.My doctor verbally informed me of this, took pictures of the broken coil with an electronic device, and stated he has reported the defect to the device representative.My doctor then proceeded with implanting the broken essure device in my body.Since that time i have suffered numerous adverse symptoms including: abdominal pain and pressure, irregular and heavy menstrual cycles, migraine headaches, joint and muscle pain, extreme fatigue, hair loss, tooth decay/loss, weight gain, bloating, vaginal pain, unexplained rashes/hives, unexplained bruising, uti, and anxiety/depression.The device is still in my body at this time.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 7780304
• MDR Text Key: 117253734
• Report Number: MW5079114
• 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: 08/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESS305
• Device Lot Number: A96181
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 113