MAUDE Adverse Event Report: BAYER HEALTHCARE LLC. ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Fatigue (1849); Headache (1880); Inflammation (1932); Itching Sensation (1943); Pain (1994); Swelling (2091); Cramp(s) (2193); Dizziness (2194); Palpitations (2467); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

Implanted with essure in 2002.Have been living with horrible side effects for 16 years.Chronic inflammation of my joints, pelvic cramping, excessive menstrual bleeding, heart palpitations, foggy memory, confusion, dizziness, dermoids, painful menstruation and swelling, abdominal pain and tenderness, migraines, back pains, constant fatigue, hair loss, severe anxiety and depression, severe itching and inflammation of hands and feet, stroke, had to live with this for 16 years.Until a hysterectomy was needed.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE LLC.
• MDR Report Key: 7805418
• MDR Text Key: 118029577
• Report Number: MW5079288
• 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: 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Hospitalization; Disability
• Patient Age: 40 YR
• Patient Weight: 68