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

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

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Rash (2033); Depression (2361); Weight Changes (2607); Heavier Menses (2666)

Event Date 09/30/2016

Event Type  Injury  

Event Description

My essure was placed approx the last week of (b)(6) 2016.Since then i've had rashes developed around joints, which wasn't present before.My depression has been much worse resulting in the addition of more medications to assist in its management.My menses have been unpredictable, happening in some cases twice a month with significantly heavier bleeding.The result of which made me go back on ocp.I have been so fatigued that i sleep for 9 hrs and still feel as though i've been awake for days straight.I feel like i'm in a fog and have difficulty recalling words, dates, phrases or terms.My weight has been all over the place and my bloating ensures that i have different pant sizes for each day.For the first time i required injections for a migraine that lasted a week straight.I feel as though the above complaints can be related to my essure device which is still implanted.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: 9596412
• MDR Text Key: 175830465
• Report Number: MW5092312
• 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: 01/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Weight: 59