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

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2013

Event Type  Injury  

Event Description

This is a follow up to the original fda adverse report dated (b)(6) 2013.My essure coil removal was unsuccessful.I had to have a second surgery this past month ((b)(6) 2018); this surgery was a full hysterectomy.Ref # 2951250-2017-01264.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7742888
• MDR Text Key: 115964316
• Report Number: MW5078804
• 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: 07/30/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 66