MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE

Device Problem Insufficient Information (3190)

Patient Problem Autoimmune Disorder (1732)

Event Date 12/06/2012

Event Type  Injury  

Event Description

Essure implanted in 2012.Multiple symptoms and autoimmune disease.Growing symptoms becoming unbearable.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7868726
• MDR Text Key: 120175881
• Report Number: MW5079716
• 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: 09/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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: 47 YR
• Patient Weight: 107