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

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Menstrual Irregularities (1959); Pain (1994); Depression (2361); Confusion/ Disorientation (2553)

Event Date 11/22/2007

Event Type  Injury  

Event Description

Have had terrible pain - debilitating menstrual cycles, brain fog, depression, horrible mood swings since the essure was placed.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7768850
• MDR Text Key: 116730606
• Report Number: MW5078976
• 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: 08/07/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 68