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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Cyst(s) (1800); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517)

Event Date 04/21/2015

Event Type  Injury  

Event Description

I had essure placed on (b)(6) 2014 and started shortly after with emergency room visits and dr visits for severe abdominal pain and random never before experienced illnesses and fatigue.In (b)(6) 2015, had a hysterectomy to remove uterus and tubes.My tubes had cysts in them which were not present before the essure placement and endometriosis was not seen during placement but was seen during hysterectomy.Now after placement have high blood pressure, diabetes, anxiety, depression, insomnia, and being tested for autoimmune diseases.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL, CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7805722
• MDR Text Key: 118109793
• Report Number: MW5079311
• 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: 08/18/2018

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: 08/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 129