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

Catalog Number ESS205

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

Patient Problems Arthritis (1723); Autoimmune Disorder (1732); Rash (2033); Skin Inflammation (2443)

Event Type  Injury  

Event Description

In late 2007 i had the essure device implanted.In 2014, i was diagnosed with a crohn's disease.Despite being treated with multiple immunosuppressants i have developed add'l autoimmune symptoms, such as eyelid inflammation, arthritis, psoriasis, and hidradenitis suppurativa near the site of the essure implant (groin).In 2018, i had a hysterectomy to remove the essure devices.The fallopian tube around one of the devices had inflammation.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC / CONCEPTUS
• MDR Report Key: 7742519
• MDR Text Key: 115935728
• Report Number: MW5078781
• 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: 07/30/2018

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
• Device Catalogue Number: ESS205
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Weight: 57