MAUDE Adverse Event Report: LAPARASCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Cramp(s) (2193); Dizziness (2194); Anxiety (2328); Irritability (2421); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666)

Event Date 12/28/2015

Event Type  Injury  

Event Description

I had a tubal ligation done after having my third child.Immediately after, i bled for 5 weeks, stopped for 1 week, and bled for another 2 more (not normal for me).After this i never had a cycle for about 3 months while breastfeeding.My milk supply was much less with my son after having my tubal than with my previous pregnancy.I started having ¿normal¿ cycles when i was about 5-6 months postpartum and they are terrible.I am bleeding much worse and is full of clots (when i say worse i mean use a 1 to 1.5 boxes of super plus tampons in 1 day and sometimes have to change the tampon 10 to 15 minutes after putting it in).I also will have a 7 day cycle but not my normal pre-tubal cycle.I now bleed for 4 days, stop for 1, and bleed for another 2 or 3 days.My cramps are out of this world, terrible.I take as much ibuprofen as the bottle says i can take, use a heating pad and it will barely touch them.I don¿t just have cramps anymore while pms and during my cycle, i also have them while ovulating.Since having my tubal, i have also gained a lot of weight (not eating any different than i have before, and have also started exercising without much of a difference).My emotions are all over the place and i¿m very irritable with everyone and have lots of mood swings.I am very anxious all the time, and have headaches and migraines much more frequently and seem to get dizzy and feel as though i¿m in a fog all the time.I also have zero interest in sex and have vaginal dryness.No matter how much sleep i get, i am tired and fatigued all the time and forget everything.I get random pains around the area of my scar and where i would think my ovaries are.Now almost every time i sneeze, sometimes when i could, i am almost always peeing myself (and yes i do kegels).If i would have known i was going to have these side effects and was told there was a possibility of it, if i had, i can honestly say that i would have never done it.

• Brand Name: LAPARASCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Type of Device: LAPARASCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8293255
• MDR Text Key: 135384816
• Report Number: MW5083575
• 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: 01/28/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 104