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

Model Number H0457364

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

Patient Problems Fatigue (1849); Flatus (1865); Headache (1880); Pain (1994); Depression (2361); Sweating (2444); Palpitations (2467); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Date 03/12/2007

Event Type  Injury  

Event Description

Had essure implanted on (b)(6) 2007 with side effects of fatigue, depression, headache, hip pain, super heavy menses, constant bleeding for almost 2 years, pain from sex, bleeding after sex, bloating, heavy sweating, brain fog and heart palpitations.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7769523
• MDR Text Key: 116932791
• Report Number: MW5079006
• 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: 08/04/2018

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: Health Professional
• Device Model Number: H0457364
• Device Lot Number: 622312
• 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 Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 76