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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Diarrhea (1811); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Tinnitus (2103); Visual Impairment (2138); Weakness (2145); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Palpitations (2467); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Started having very heavy and painful periods, (feels like i am being stabbed by a knife or my insides are ripping apart) after essure was implanted.Migraines, severe fatigue to the point that i can barely take care of my house and 4 children, let alone go back to work after baby, hair loss, joint and muscle pain and weakness, unexplained rashes, nausea, diarrhea or constipation, bloodwork always off with no known cause, severe lower back pain, pain in lower abdomen and hips, dizzy spells, brain fog, memory issues, concentration issues, vision problems, weight gain and now weight loss, irregular heartbeat, heart palpitation, arrhythmia, now high blood pressure which has never been a problem for me even through 4 pregnancies, severe anxiety, tinnitus that is constant and never goes away.Have not had x-rays done since initial hsg.Have no idea if devices have migrated or punctured anything.All symptoms of inflammation and nickel poisoning.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: 9641932
• MDR Text Key: 177030109
• Report Number: MW5092602
• 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: 01/24/2020

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
• Device Model Number: ESS305
• Device Lot Number: B60746
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 49