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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 03/09/2009

Event Type  Injury  

Event Description

Essure placed following birth of last child.Had immediate weight gain.Over the past 10 years, a number of health problems have occurred.Severe hair loss, migraines, trichodynia, phantosmia, anxiety, insomnia, heavy bleeding during menstrual cycle, large blood clots during menstrual cycle, depression, memory loss, and severe dental problems including the loss of all natural teeth.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8382159
• MDR Text Key: 137669213
• Report Number: MW5084558
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Disability
• Patient Age: 46 YR
• Patient Weight: 64