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 Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Weight Changes (2607); Heavier Menses (2666)

Event Date 03/31/2011

Event Type  Injury  

Event Description

I started having horrible pelvic pain, ridiculously heavy periods, mood swings, constant fatigue, terrible joint pain, skin rashes that wouldn't go away, dry patches of skin, memory loss, dental problems, hair loss, unexplained weight gain and migraines.This continued for 8 years before i could get a doctor to help me.I was diagnosed with post essure syndrome and i have a hysterectomy scheduled for (b)(6) 2019.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8253662
• MDR Text Key: 133689365
• Report Number: MW5083162
• 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: 01/11/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 23 YR
• Patient Weight: 68