MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Numbness (2415); Cognitive Changes (2551); Weight Changes (2607)

Event Date 01/03/2014

Event Type  Injury  

Event Description

Reporter stated that she had an ablation done in 2014 and essure was implanted at the same time.After a year, she observed pelvic pains.Six months later, her right leg and arm started getting numb.Since 2017, the pelvic pain has intensified and now radiating to her hip.She has gain substantial weight of approx 50 pounds in 3 years.Reporter has bouts of headaches and takes ibuprofen for that.She has brain fog and forgets regularly.She is scheduled for a hysterectomy on (b)(6) 2018.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7822257
• MDR Text Key: 118559239
• Report Number: MW5079435
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 137