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

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

Patient Problems Stroke/CVA (1770); Dry Eye(s) (1814); Hair Loss (1877); Headache (1880); Incontinence (1928); Memory Loss/Impairment (1958); Tinnitus (2103); Blurred Vision (2137); Hot Flashes/Flushes (2153); Tingling (2171); Numbness (2415); Collapse (2416); Sweating (2444); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Abdominal Distention (2601); No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Event Description

I had my tubes tied through cut, tie, burn method (known as a pomeroy).Six weeks later, i went to the er with severe ovarian pain, hot flashes, night sweats, blurred vision, urinary incontinence, insomnia, kidney pain, flank pain, hair loss, mental confusion, memory loss (short term), ringing ears, dry eyes, nasal passages, a burning tongue, dry vagina, bloat and ibs like symptoms.I continued to worsen in the weeks following my bladder prolapsed at 10 weeks post tubal, then 15 weeks post tubal i had a stroke like event where my right side went numb and i collapsed.I also had numbness on the right side of my face, my hands and feet tingled and migraines.I was not informed that these side effects would happen.Please look into this, so no other women have to suffer.I had gone into hormone shock.

• Brand Name: TUBAL LIGATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8281713
• MDR Text Key: 134568292
• Report Number: MW5083423
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 85