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

Patient Problems Arrhythmia (1721); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Constipation (3274); Unspecified Kidney or Urinary Problem (4503); Breast Discomfort/Pain (4504); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/29/2013

Event Type  Injury  

Event Description

I had my tubes tied after childbirth.These side effects started almost immediately.Panic attacks, joint pain, memory loss, extreme weight gain, constant bleeding for months, rage, anger, removed libido, hair loss, depression, crying, loss of emotion, constipation, debilitating cramps, back pain, kidney pain, forced menopause, night sweats, hot flashes, exhaustion, sleep disturbances, mood swings, anxiety, irrational fear, bloating, agitation, blurry vision, aggressions, bone pain, cravings, misery, brain fog, heart palpitations, extreme ovarian pain, migraines, itching all over, urinary incontinence, quick temper, dry peeling skin, forgetting what to say, short term memory loss, can't concentrate, claustrophobic, lethargic, can't get enough sleep, brittle nails, weak nails, peeling nails, angry feelings, agitated, emotionless, brown patches on my face, scalp psoriasis, confusion, breast pain, lack of self confidence, irrational thought processes, shortness of breath.My dr.Told me there were no side effects of getting my tubes tied.I did not have any of these symptoms before i did.This procedure has ruined my life.Ruined it completely.When i went back to see my dr.She said she had never heard of any side effects from this procedure, and gas lighted me.When i contacted the hospital for my surgical report, they said they had no records of my procedure.

• Brand Name: TUBAL LIGATION BANDS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19090543
• MDR Text Key: 340132771
• Report Number: MW5153755
• 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: 04/06/2024

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White