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); Memory Loss/Impairment (1958); Pain (1994); Skin Irritation (2076); Sleep Dysfunction (2517); Cognitive Changes (2551); Abdominal Distention (2601); Constipation (3274)

Event Date 12/05/2008

Event Type  Injury  

Event Description

I had the essure implanted in (b)(6) 2008 for permanent birth control.For years i have been suffering with pelvic pain, headaches, fatigue, insomnia, skin irritations, bloating, constipation, sexual libido, vitamin d deficiency, brain fog, memory loss, neck/back pain.After 10 years i discovered essure is made of nickel coils causing me side effects for years.Sadly i had a bilateral hysterectomy on (b)(6) 2018.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8212845
• MDR Text Key: 132123733
• Report Number: MW5082782
• 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: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• 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): Hospitalization; Other
• Patient Age: 32 YR
• Patient Weight: 70