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

Model Number ESS305

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

Patient Problems Cyst(s) (1800); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Rash (2033); Blurred Vision (2137); Depression (2361)

Event Date 03/01/2010

Event Type  Injury  

Event Description

I was implanted with essure device on (b)(6) 2009.About 6 months later, i was diagnosed by my dr as peri-menopause and had to begin hormonal treatment.I was (b)(6) y/o.Since the device was implanted, i have suffered from the following conditions which drs have not been able to explain other wise: migraines, headaches, foggy thinking, depression, female hormone imbalance, cystic acne, extreme dry skin, eczema, rash on face, blurry vision, fatigue.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8612638
• MDR Text Key: 145264841
• Report Number: MW5086655
• 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: 05/13/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: ESS305
• Device Catalogue Number: 663256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 33 YR
• Patient Weight: 52