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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Confusion/ Disorientation (2553)

Event Date 06/30/2007

Event Type  Injury  

Event Description

I had the essure implanted in (b)(6) 2007 and ever since have been bleeding excessively, chronic pain, brain fog, fatigue, teeth breaking, hair thinning, high blood pressure.I've had a hysterectomy and bilateral salpingectomy to remove the essure from my body.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 8735257
• MDR Text Key: 149467630
• Report Number: MW5087616
• 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: 06/21/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 48 YR
• Patient Weight: 90