MAUDE Adverse Event Report: TUBAL LIGATION CUT AND BURNED ; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Anemia (1706); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Fungus (1872); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Thrombus (2101); Blurred Vision (2137); Hot Flashes/Flushes (2153); Tingling (2171); Anxiety (2328); Depression (2361); Sweating (2444); Abdominal Distention (2601); Heavier Menses (2666)

Event Date 05/06/2008

Event Type  Injury  

Event Description

By tubal ligation syndrome started immediately after my tubal ligation.I first noticed major dizziness, fatigue, mind is foggy, add, shortness of breath, worsening, allergy symptoms, shooting pains in my pelvic area, heavy bleeding, golf ball size clots, anemic, mood swings, anxiety, depression, pain with sex, zero sex drive, vaginal dryness and frequent yeast infections, bloating to the point i looked six months pregnant and head aches.That was the first year of post tubal ligation.Over the years it keeps getting worse.My depression has worsened, anxiety has worsen.I have blurry vision, more problems with my teeth, constant aches in my pelvic area, tingling in my extremities, cold sweats, hot flashes, bad bo along with chills and always cold.Hair loss and alzheimer's like moments during conversation or tasks.Surgical procedure.Fda safety report id# (b)(4).

• Brand Name: TUBAL LIGATION CUT AND BURNED
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8555751
• MDR Text Key: 143452591
• Report Number: MW5086219
• 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: 04/23/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 52