MAUDE Adverse Event Report: FALOPE RINGS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Arthritis (1723); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Headache (1880); Menstrual Irregularities (1959); Hot Flashes/Flushes (2153); Irritability (2421); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); Alteration In Body Temperature (2682); Constipation (3274)

Event Date 09/23/2015

Event Type  Injury  

Event Description

I had a tubal ligation using falope rings.I woke from surgery screaming out in pain in my lower abdominal area.This pain lasted a year and a half on my right side.A day after surgery i developed a migraine, the first ever in my life.Over the next several months, i noticed many changes with my body and mental health.These symptoms are: menstrual migraines, insomnia, night sweats, hot flashes, chills, decreased sex drive, vaginal dryness, irregular periods, dried up breast milk, extreme irritability, anger, mood swings, feeling of disconnect, feeling of doom, weight gain, constipation, brain fog, fatigue, lack of motivation / drive, heavy bleeding (period), osteoarthritis in knees, pms, pounding heartbeat, the need to catch my breath.Overall change in who i was, which has caused me to lose precious time with my children as the pt involved mother that i used to be.My gynecologist said he does not believe in post tubal ligation symptoms and said all symptoms are coincidental.

• Brand Name: FALOPE RINGS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8231870
• MDR Text Key: 132808962
• Report Number: MW5083015
• Device Sequence Number: 1
• Product Code: KNH
• 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: 01/07/2019

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: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Weight: 89