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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Nausea (1970); Rash (2033); Swelling (2091); Swollen Lymph Nodes (2093); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Confusion/ Disorientation (2553); Weight Changes (2607); Fibrosis (3167)

Event Date 08/26/2011

Event Type  Injury  

Event Description

Pain in abdomen, swelling and pain in joint, fibromyalgia.Migraines, nausea, fatigue, brain fog; skin rashes, swollen lymph nodes, weight loss, anxiety.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7725628
• MDR Text Key: 115367158
• Report Number: MW5078634
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 53