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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUTTING LOOP MONOCULAR

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CUTTING LOOP MONOCULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Internal Organ Perforation (1987); Heavier Menses (2666); Fibrosis (3167)
Event Date 12/02/2001
Event Type  Injury  
Event Description
I had a myomectomy surgery with morcellation of a fibroid in my uterine wall.Immediately following the surgery i could not think the same, my cognitive skills seemed affected, my breathing never recovered.My wind capacity forever gone in my chest, my lung.I bled two weeks out of every month hemorrhaging immediately following surgery.I pulled a [invalid] of what looked like hot dogs of my flesh from my vagina.Had to bear down every month and push tissue out of my vagina.Mine was not containable anymore with super tampons and super pads.I had to wear adult diapers.I would have flooding gushing from my vagina without any warning.I eventually had to have transfusions and finally a hysterectomy in 2007 in which they cut my bladder.The surgery ruined my female organs and i wanted to have children.It seemed to burn me and cut me up.I feel like i have fluid absorption when i had my hysterectomy.The doctor said i had maybe a nickel size uterus left and had grown into my uterus was a melon sized fibroid that consisted of five lemon size fibroids.I was told that morcellation causes fibroids which have seeds like warts to be spun and seated into my uterus and i grew this hideous huge mass from what was a surgery that was to get rid of one small 3 millimeter fibroid.It was monocular cautery with a cutting loop and call me forcep; it was at (b)(6).Dr (b)(6), if he did not report this he should have at the time, i am still unclear what cautery company 4 cautery tools was used but the compressor was the force fx.I lost my job, my ability to have a family, a husband, a life i wanted.I lost my home.I had a mental breakdown.I lost my friends, my family, i lived in my car for two and a half years.Prior to the surgery i had just gotten back from (b)(6).I was a social (b)(6) girl with a good career.I was self-sufficient, i made plenty of money, i rented a home, i have two cars, and i lived on my own.It was supposed to be a simple procedure the doctor said it would help my bleeding that was heavy but not problematic by any means like after the surgery.I also want to note i was very athletic, i ran all the time.I had huge lungs as i swim in a pool we had in (b)(6); most of my life from the very beginning.I had huge lung capacity in spite of my smoking.I do not smoke today and i'd smoke off and on when i was younger.This was heavily noted in the notes when i had the surgery, in the surgery report recently.I believe it's because it affected my heart and lungs they were never the same.Whatever happened that surgery something that i believe it was saturation.One thing i remember from surgery is the nurse saying oh never mind she's a smoker.She won't ever be able to blow the ball up high.They ignored obvious signs of problems after surgery.My uterus with this monocular cutting tools i would really appreciate trying to know what company made these so i could get some sort of compensation, if possible.I'm having pain to this day and the right side and tired and possibly with cancer unk at this moment.I'd like to take note nothing was known at the time no one sees your blood from your period.It's inappropriate to talk about.So my life took a turn for the worst; my dad didn't want to hear about my periods.My family was angry, i would immediately get a hysterectomy.I was not supported in anyway.No one can see the blood from your vagina.It's not like it's your arm gets cut off.You can help me or anybody else with this story.Please take responsibility and do thank you for your time and letting me tell someone about this and to suffer during a time when no one talked about this it just sounded strange to say you bled like that no one had every heard of bleeding like that.It was inappropriate so it caused major social problems and i ended up in isolating myself and walking out of my life.To this day i can hardly breathe.I cannot pick up a box it's too hard on me.I have no energy.
 
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Brand Name
CUTTING LOOP MONOCULAR
Type of Device
MONOCULAR
MDR Report Key5744515
MDR Text Key48199465
Report NumberMW5062991
Device Sequence Number1
Product Code HIH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/20/2016
3 Devices were Involved in the Event: 1   2   3  
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 Received06/20/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age36 YR
Patient Weight67
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