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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Connective Tissue Disease (1786); Inflammation (1932)

Event Date 09/13/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 i had my fourth joint surgery.This one was my right shoulder.I have now been diagnosed with connective tissue disease, and soft tissue rheumatism, along with several other auto immune diseases after being implanted with essure.This adverse event is not the first report i have filed due to problems from the medical device.But i wanted to document the new diagnosis and the surgery.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): CONCEPTUS / BAYER HEALTHCARE LLC
• MDR Report Key: 7938606
• MDR Text Key: 123155500
• Report Number: MW5080379
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 46 YR
• Patient Weight: 57