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

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Emotional Changes (1831); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Myalgia (2238); Numbness (2415); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 12/13/2018

Event Type  Injury  

Event Description

On this date, i had surgery for bilateral salpingectomy to remove essure devices.My side effects of essure included: chronic fatigue, numbness in hands and fingers, chronic pain in both hips, chronic ham and calf muscle aches, memory difficulties (forgetfulness) and confusion, night clenching resulting in jaw pain, severe cystic acne, and unpredictable mood swings.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8199851
• MDR Text Key: 131926957
• Report Number: MW5082639
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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 Age: 42 YR
• Patient Weight: 60