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

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Pain (1994)

Event Date 08/28/2019

Event Type  Injury  

Event Description

Essure devices placed in 2011.Traumatic insertion with spasm of tubes causing severe pain; 2014-2015 heavy menstruation started require ablation with anemia.Pelvic pain and tailbone pain started (b)(6) 2019 that progressively worsened to include abdominal pain.Gyn exam with hysteroscopy on (b)(6) 2019 unable to confirm left tube placement due to pain during exam.Recommended essure device removal including tubes arteriovenous anastomoses uterus.Surgery done on (b)(6) 2019 with relief of pain in pelvic; tailbone and abdomen.Fda safety report id# (b)(4).

• Brand Name: ESSURE CONTRACEPTIVE DEVICE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL, OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 9134615
• MDR Text Key: 160568401
• Report Number: MW5090092
• 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: 09/26/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATIVAN ; CBD OIL ; CYTOMEL ; HYDROCODONE; LEVOTHYROXINE; MELATONIN ; MOTRIN ; PYRIDIUM ; VITAMIN D
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 87