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

Device Problem Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Pain (1994)

Event Date 01/01/2008

Event Type  Injury  

Event Description

After having my fifth child in (b)(6) 2007, dr introduced essure and i believe 1 year later i started having severe chronic pain.Seen an ra specialist, diagnosed me with rheumatoid arthritis.Autoimmune.I believe ever since the essure i started having chronic pain.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7769418
• MDR Text Key: 116785768
• Report Number: MW5078999
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 37 YR
• Patient Weight: 74