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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. HELICAL STONE BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

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C.R. BARD, INC. HELICAL STONE BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number 040490
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Rupture (2208); Anxiety (2328); Fungal Infection (2419); Choking (2464); Sleep Dysfunction (2517); Abdominal Cramps (2543); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Abdominal Distention (2601); Tissue Breakdown (2681); Unspecified Immune System Problem (4435); Localized Skin Lesion (4542)
Event Date 01/28/2020
Event Type  Injury  
Event Description
(b)(6) 2023; hello, i'm filing a fraud case against c.R.Bard, inc - from (b)(6), (b)(6) 2013.Surgery prolapsed bladder sling ¿ dr.(b)(6), i was completely unaware that i had any type of sling other than the first one i had ever had, which was from the thigh of the cadaver using the muscle of a cadaver.This surgery was on (b)(6) 2013 in his surgery center.((i didn't know i had a mesh sling inside of me until i saw the urologist in (b)(6) 2019)) (b)(6) 2013 i saw dr.(b)(6) as i was experiencing stomach issues, horrific pains, and unexplained pain in my right lower back.I had not hurt myself, anything.I had terrible unexplained gagging at times, vomiting if i even took a drink of water, choking, and would have to run to the sink when i laid down; my sons started asking me the last few months what was wrong.I would make up things as i choked on gum or candy.Whatever i could think.Going to the bathroom became an issue.I went to see dr.(b)(6), and he admitted me immediately into the hospital from his office.After a few tests, he informed me that my gallbladder had ruptured.He was shocked as i was, and then speaking with the doctor who performed the tests on me, he asked me if i had any signs, and i explained the choking, vomiting, and other things.The start of many illnesses, hospital visits, and my body slowly deteriorating over these past years.Finding the mesh on (b)(6) 2019 was the last puzzle piece.The final puzzle part was finding the "claim form from cr.Bard to regence, as in the correspondence from regence, dr.(b)(6) office, originally just sent them a bill, wanting them to pay dr.(b)(6) office for charges, and they were going to reimburse cr.Bard, when regence sent a letter to dr.(b)(6) office stating they would not pay until they received further information to process this claim.I never felt the same after recovering from the second sling for my prolapsed bladder.Approximately six months later, i started smelling the worst foul odor in my vagina.I could smell it just sitting or standing.I would take a shower, sometimes a few a day, and i would smell it immediately.It was not a urine smell, just the worst smell you could imagine.I often went to the doctor and received the same diagnosis every time.(bacterial vaginosis) they would call in an antibiotic and a cream.For the first few years, i would go on the medication.It did nothing except give me a yeast infection.I'd then have to go back in and get a script for a drug for the yeast infection.The cycle began for years.The odor was so foul that i had to stop wearing jeans, pants, and shorts.I could only wear dresses.After a couple of years, i could not afford to keep buying pants, shorts etc, as i couldn't even get the smell out of them.I started living a nightmare, and i stopped telling the doctors about the foul smell as no doctor ever looked past what i explained.I just gave up and figured there was nothing i could do, that i just had to live like this.I've been sick every day since dr.Wall implanted a mesh knowing what it would do to me.Worst of all, they are not asking me or giving me a choice.As you and i both know, dr.(b)(6) and cr bard knew that the fda issued its first severe warnings in 2008 and 2011.Just to confirm this is about the medical device, i just wanted to explain how this all happened.(i had a choice then, and dr (b)(6) did not give me a choice, he played god, or he chose the money over my life) now in the condition my body is in, i have no choices) in anything) (would he have done that to his wife, mother.Sister, in 2012 six months before my surgery, he implanted with one of their mesh products.C.R.Bard (bard) withdrew its avaulta plus and align vaginal mesh from the market in july 2012, weeks before losing a verdict to a woman who experienced complications from the device.The same thing happened with the horrific pain, being unable to sit, entertain anymore, and slowly but surely being able to go out.My body started giving me fatigue.I would go grocery shopping, cook meals, and do ordinary things.My lower back, my groin area, would be in such pain, on fire, i could barely walk, and if i sat on the couch to watch tv with the kids or myself, i would have to lie down as if i sat my pelvic would hurt so badly, that i constantly had to move and readjust.Over time, months, and years, i would go to the movies, a meal, my son's football games in college, and his track meets, i couldn't even sit in the bleachers, and if i brought my chair, i would still be readjusting all the time.I felt conscious about it and knew people noticed, but i would be too tired to stand the entire time.I'd bring a blanket on lovely days and try to lie on one buttock.I could honestly feel my body deteriorating, but no one, not one doctor, nor did i know why.(b)(6) 2013 ¿ i started experiencing extreme pain in my lower back, bringing me to my knees.I have a very high pain tolerance that has landed me in the er and numerous hospital stays with serious infections/surgeries throughout my life.All due to the fact i had no idea i had anything wrong, as until i feel the pain, it is at least a 15-18+ and always gets me into trouble.I began experiencing excruciating pain just preparing a meal from scratch for my sons and their friends.(from grocery shopping to unloading the car and making the meal) (this has always been one of my many passions).From planning my meal to creating a new signature cocktail, grocery shopping, and getting those unique ingredients and fresh items, i started feeling like my grandma, hunched over, hit by a car in my lower back and front organs.My oldest son would notice and ask me secretly, are you ok? you're limping, or mom, why are you hunching over? i would tell him i had slept funny and tweaked my back.I started experiencing severe pain in my hip, groin, and leg.The pain became neverending.I have spent weeks, sometimes months, in such pain and fogginess.Just thinking about having to get up to get groceries was a chore.The mesh started destroying my life within six months of being implanted in 2013.And at this present time is still ruining my life.I started worrying, and on days i didn't do too much, i'd just put it out of my head, as i didn't have time to worry, nor was i able to think, as i had to go on.I was a single mom with two sons, and it scared me.I felt like i was doing too much, which was starting to scare me; by the time i cleaned up the kitchen in agony and, at times having to drag the garbage bags to the cans outside as i could barely lift them, i was in so much pain, but i never quit as to me there was no reason for any of this.I had no injury, and if something was wrong with me, i had no choice but to keep going.I was a single mom.I was always used to doing it all, as i had been a single mother since my children were young, grades 2nd, 3rd, and 5th, and then permanently separated on paper in 2005.I kept praying that i didn't have bone cancer, etc.Honestly, i didn't have a choice, and when the boys left for college and were only home for dinner with friends or holidays, i could rest and hide it from them.But never able to stop, as i have no family and had to keep going as a single mom with an ex that is bipolar and an alcoholic, and i was the stability and parent for my sons.I started gagging for months, choking and throwing up, etc.And saw a surgeon in the fall to have some horrific hemorrhoids removed, and two days later, my gallbladder burst.My gallbladder flaring six months after my mesh was the first of many things/illnesses that happened to me after the new mesh sling that i still was unaware was a mesh sling.I started having a horrific odor that doctors would prescribe, an antibiotic cream, and an antibiotic, which never disappeared.By the end of 2013, i could no longer wear pants or shorts, as i could not afford to wear a pair once, throw them away, and purchase a new team.So i had to wear dresses.Every doctor i saw told me i had a vaginal discharge or a bacterial infection.I kept telling them it had to be more throughout the years, but no one listened.My stomach started getting distended; the cramping would drop me to my knees and bring me to tears often.Many days when this happened, i looked like i was pregnant, had hospital stays, and was seeing gastrologists, all promising they could fix me, and always, in the end, i was the big mystery, the weird patient.That's all i kept hearing from every doctor.I don't even remember the doctors i have been to and how many.I stopped going about the horrific odor at times, as they all put me on the same meds, and they never worked.I was so miserable and so shocked by our medical system and doctors.I tried holistic medications, and at night and during the day, i would like meloxicam, tramadol, oxycodone, etc.I finally got my medical cannabis card while living in (b)(6).I got relief from national products, which helped me get through the day and sleep through the night from the debilitating pain and inflammation.With the emotional toll, physical toll, and robbed of my life since february 2013, i'm not sure how to live anymore or how it is to live in the outside world.At times i think if i was out with people, could i hold a conversation and be engaging* i've lost jobs; i would get such terrible bouts of pain, diarrhea, fatigue, and headaches, and i couldn't sit up and sleep and had it.I have my entire abdomen eroded, but my immune system has been compromised, not being able to fight off any infections, anything since dr.(b)(6) implanted the mesh sling, genuinely from the inside out.For instance, in one of my jobs, i had one as a professional recruiter, and my boss and co-workers made fun of me for having to use a medical pillow on my chair for my back and buttocks.The medical seat pillow allowed me to sit for a few hours and helped ease some of my pain without sharing how much pain i was.I was eventually fired and ridiculed for walking and my skin, no one wanted to be around me and told i walked at times like an old lady and should be at home collecting disability.I had to file for bankruptcy, chapter 7 and received a complete discharge of all debts in february 2021.I had to move in with my family in september 2019 after living on the west coast since 1996.May 2014 ¿ relocated to (b)(6).(b)(6) 2014, i started breaking out in sores all over my neck, head, face, back, arms, legs, basically everywhere.It became so horrific that when i would go to the pharmacy to pick up my medicine, people would look at me in line and get out of line if they were in front or back.My eldest son saw me a few months later and asked me what had happened.I honestly couldn't tell him.I had tests done, biopsies, and more meds, and it just worsened year after year.I wore dresses but had to wear long sleeves and hide my entire body.I remember going to a new doctor in 2018 as i had gotten a horrific case of shingles on my face and neck and had no idea as my body by this time was so plagued by sores everywhere, and i was so used to being in pain from the inside out and feeling like i was on fire.He looked at me, told me i had shingles and prescribed medication.Reference reports mw5119798, mw5119799.
 
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Brand Name
HELICAL STONE BASKET
Type of Device
DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
C.R. BARD, INC.
MDR Report Key17373325
MDR Text Key319669221
Report NumberMW5119800
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040490
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
BUPROPION 150 MG XL TABLET; CLONAZEPAM 1 MG TABLET; DUPIXENT PEN 300 MG/2 ML PNIJ; ESCITALOPRAM OXALATE 20 MG TABLET; LEVOCETIRIZINE 5 MG TAB; MAGNESIUM; MELOXICAM 15 MG TABLET; MONO DOXYCYCLINE 200 MG, TWICE DAILY; SUMATRIPTAN 100 MG TABLET; TEMAZEPAM 30 MG CAP CAPSULE; VALACYCLOVIR 1 GRAM TABLET; VITAMIN C; WOMEN VITAMIN
Patient Outcome(s) Other; Disability; Hospitalization;
Patient Age56 YR
Patient SexFemale
Patient Weight66 KG
Patient RaceWhite
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