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

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Memory Loss/Impairment (1958); Rash (2033); Swelling (2091); Numbness (2415); Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Date 02/10/2011

Event Type  Injury  

Event Description

Since i have had the essure implanted in 2011, i have experienced the following: very severe migraines, two abnormal pap smears ( in my entire gyn history of never having any), constant abdominal bloating, constant brain fog, nickel allergy rashes, horrible food allergy to milk with swelling in face and inflammation in ears, numbness in thighs and legs, insomnia and chronic fatigue.I had constant ear infections in 2013 that i am now allergic to amoxicillin.I still get them.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 7960366
• MDR Text Key: 124879545
• Report Number: MW5080514
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• 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): Disability
• Patient Age: 38 YR
• Patient Weight: 81