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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON MEDICAL GMBH / ETHICON INC. TVT SLING MESH MESH, SURGICAL, POLYMERIC

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JOHNSON AND JOHNSON MEDICAL GMBH / ETHICON INC. TVT SLING MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Perforation (2001); Ambulation Difficulties (2544)
Event Date 08/09/2011
Event Type  Injury  
Event Description
I was given the tvt sling by johnson and johnson. The polypropylene mesh cut my stomach and nerve severely. I'm now retired from (b)(6) as a mail carrier. My family has to care for me. My husband was also injured while having marriage intimacy. The sling attached itself to my collagen and after removal, the surgeon told me he could see straight through my appendix. I have feeling in my left thigh and the pain starts in my upper pelvic area, after 10 minutes the pain moves inside the buttock nerve and down the right side of my leg. A lock stiffness start stopping me from walking normally and last over 8 hours. I have to have a portable toilet because i have no way to walk to the bathroom. After pain medication and no move moment in 24 hours, i can get up and walk to the toilet and shower only. If i continue to move in a walking position, the pain results back the becoming to stiff and locked nerves to walk. The tvt mesh sling stabbed myself and cutting into my nerves for a year after 30 days of none movement. After the last tvt sling was removed back in 2013, the surgeon informed me that the tvt mesh sling was falling into my bladder and would have punctuated more cuts into my bladder as long as i would have kept the tvt mesh sling wrapped around my bladder. I was not told by the doctor or hospital that this was a experiment and i was going to become a disabled and lose my career never to care for my family again. Today is april 17, 2021. I still live with this condition and have never gained the normal ability to walk run sit stand dance jump move exercise around as a normal woman as i was. While i do not understand why this device was made to destroy women on purpose. But men have to understand that butchering and slaughtering women for money please remember you have and have a mother and treating women this badly is cruelty to women. Not caring about women for money is a horrible belief to make us suffer. I do not know why u have so much hatred for women but that one day will stop. These devices have stopped women at age 89 for reason none of the family members request but doctors were told it is ok to lie. I have only one thing to tell you and you will pay mentally and physically for your hatred now that i have written to you. I asked you in 2015 to stop this device and take it off the market. You want your daughter and her daughter and her daughter to suffer with a sling. As long as you see your very own female humans born the tvt sling mesh will slaughtering and butchering to your families unless you remove it forever right now. You all are not stupid so this is common sense to female humans that walked this earth and you know just how much you hurt women for decades leaving this device tvt sling mesh on this earth. But as i write about issues people in charge of other people's life. Goes around comes around. Remember i warned you to love women because they we are suffering because of you. Looking at money and you also hate women too please your satanic behaviors. A spirit being will come for you, and you will answer for the hatred for women females that never hurt slaughtering butchering to you but you want to hurt them us. I want to tell you that as you live your life daily you will remember this letter. As long as you do nothing to stop tvt sling mesh slaughtering butchering women, your lives and your families live want never to the same because as we all learned once you know the truth and you still did nothing to change it and you could have the burden is on your soul. The spirit has no face clothes are of a knight. I know because after my last operation i die and saw it and was asked if i want to go and i knew before i die off women needed to know just how much we are hated by man kind. I dont have much space left so again tvt sling mesh by johnson and johnson is no good for animal. Inside women its worse please take it off the market and never use it no matter what happens in this world. Fda safety report id# (b)(4).
 
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Brand NameTVT SLING MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON AND JOHNSON MEDICAL GMBH / ETHICON INC.
MDR Report Key11694668
MDR Text Key246308551
Report NumberMW5100863
Device Sequence Number1
Product Code FTL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2021 Patient Sequence Number: 1
Treatment
CARVEDILOL
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