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

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

Patient Problems Autoimmune Disorder (1732); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Cramp(s) (2193); Pressure Sores (2326); Cognitive Changes (2551); Heavier Menses (2666)

Event Date 11/01/2012

Event Type  Injury  

Event Description

Had essure implanted and all kinds of issues since.Pains, heavy periods, swelling in my entire right side, leg cramps, sores on my head, reynauds.Memory issues, brain fog.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TOBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 100 bayer blvd; whippany NJ 07981
• MDR Report Key: 8150986
• MDR Text Key: 130034347
• Report Number: MW5081998
• 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: 12/07/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 65