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

Device Problems Migration or Expulsion of Device (1395); Misfire (2532)

Patient Problems Abdominal Pain (1685); Headache (1880); Pain (1994); Urinary Tract Infection (2120); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 03/11/2011

Event Type  Injury  

Event Description

I had essure placed in 2012.Shortly after having pelvic pain and abdominal bleeding along with headaches, frequent uti and dyspareunia.When the essure was placed one of the coils was misfired into my uterus.I recently learned that one of my coils had migrated halfway out of my tube.On (b)(6) 2018 i had to undergo hysterectomy due to the essure coils.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 8199645
• MDR Text Key: 131700450
• Report Number: MW5082621
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 77