MAUDE Adverse Event Report: BANDED TUBAL LIGATION; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Hot Flashes/Flushes (2153); Anxiety (2328); Irritability (2421); Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Date 03/27/2015

Event Type  Injury  

Event Description

I got my tubes banded (b)(6) 2015.I have had nothing but severe stomach pains, nausea, bloating, mood swings, irritability, severe pain during menstrual period, suicidal thoughts, hot flashes, insomnia.I now have pelvic congestion syndrome because of my tubes being banded.Loss of libido, dry vagina, anxiety, breast tenderness etc.I have been suffering with severe pains and everything above and more for four years now.I have talked to a lot of women, over a thousand, that have been suffering as i have been and nothing has been done.There are women on a daily basis that think about committing suicide instead of dealing with the pain because our drs didn't tell us the side effects to getting tubal ligation.It is too expensive to get a reversal.Fda safety report id# (b)(4).

• Brand Name: BANDED TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8658185
• MDR Text Key: 146647460
• Report Number: MW5087025
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 30 YR
• Patient Weight: 54