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 Memory Loss/Impairment (1958); Pain (1994); Anxiety (2328); Depression (2361); Weight Changes (2607)

Event Date 11/12/2012

Event Type  Injury  

Event Description

Had essure implanted since then have been diagnosed with pelvic congestions syndrome, have pain in my pelvic region.Depression and anxiety have gotten worse, lower back pain, problems with my teeth diagnosed with piriformis syndrome, weight loss (not sure if this is related or not), memory problems which i did not know what was going on until reading others side effects from essure.I am scheduled for removal of my uterus and fallopian tubes (to remove the essure) on (b)(6).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8023962
• MDR Text Key: 126062268
• Report Number: MW5080966
• 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: Other
• Type of Report: Initial
• Report Date: 10/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 51