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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Cramp(s) (2193); Confusion/ Disorientation (2553)

Event Date 07/21/2015

Event Type  Injury  

Event Description

Essure implant.Side effects included cramping, pelvic pain, abdominal pain, heavy bleeding, headaches, brain fog, ovarian cysts.Hospitalization on multiple occasions.All resulting in a full hysterectomy.

• Brand Name: ESSURE
• Type of Device: TRANSVERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7450373
• MDR Text Key: 106302025
• Report Number: MW5076627
• 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: 04/19/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 57