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); Autoimmune Disorder (1732); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Pain (1994); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 09/01/2009

Event Type  Injury  

Event Description

Had essure implanted in (b)(6) 2009.Since then i have had metal taste in mouth, severe pelvic pain, abdominal swelling, loss of hair, severe headaches, weight gain, multiple infections, brain fog, heavy long menstrual cycles, developed autoimmune diseases.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL, CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8200048
• MDR Text Key: 131929137
• Report Number: MW5082641
• 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: 12/21/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 36 YR
• Patient Weight: 95