MAUDE Adverse Event Report: MEDICAL CORPORATION HERNIA MESH (POLYPROPYLENE); MESH, SURGICAL, POLYMERIC

Medical Device Problem Codes	Contamination (1120); Defective Device (2588); Unintended Movement (3026); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Cardiac Arrest (1762); Fistula (1862); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Distress (2329); Impaired Healing (2378); Coma (2417); Quadriplegia (2449)
Date of Event	10/23/2019
Type of Reportable Event	Death
Event or Problem Description
My name is (b)(6) the son of (b)(6) who died as a result of defective hernia mesh products, specifically bard doval and covidien as well as a third product i believe.I was my father's care provider for the last three years of his life as his condition became severe and debilitating.In 2019 he went in for emergency surgery due to a life-threatening bowel blockage that became septic.It took 11 days for him to wake up and he never walked again for the last two years of his life.When i met with the surgeon dr.(b)(6) he stated "this was one of the most difficult surgeries he ever performed".Bear in mind dr.(b)(6) had been performing surgeries for 35 years to put that statement in perspective.The products used in my father's hernia surgeries destroyed his internal organs to the point they had to be removed and resected.His organs were dead, dying, perforated, and so on.Everything i speak about in this email is fully documented in his medical records.I personally spent 3 years reading through every page and going over them with a fine-tooth comb.I sold my home and left my career as a mortgage compliance officer to live with my father the last 2-2.5 years of his life to take care of him 24/7 as my mother, his wife passed away in 2011.After his last hernia mesh revision surgery in 2019 due to a bowel blockage he never recovered.He suffered extreme neuropathy, functional quadriplegia, large abdominal wounds with fistulas that i had to pack every day, numerous uti's from his catheter, etc.In the weeks following his surgery his surgeon had to pull mesh through his fistulas during an office visit due to the extreme pain he was in.I spent two years listening to him crying out in pain and sobbing on a daily basis, and unless you've watched a parent suffer like that you have no idea what it does to you.His wounds never healed due to the mesh infection.I had to call 911 over 20 times in the last year of his life and he had to endure the pain of traveling to the hospital and the pain was excruciating.His quality of life was gone completely.My father died a very slow, agonizing, depressive, demoralizing, tortuous death, to put it mildly.These are facts.Trust me, i had the traumatizing task of being there 24/7 throughout the entire 2 plus year ordeal.Make no mistake he suffered from every hernia mesh complication you can find on google plus the extreme neuropathy, function quadriplegia, and death.He could not walk, feed himself, bathe, use the toilet, scratch his nose, pet his dog, or anything else for that matter.Nobody should ever have to go through the hell my father, myself, and my family went through due to these medical products.It was a tragedy of epic proportions for all of us to say the very least.Reference reports mw5171291, mw5171292.

• Brand Name: HERNIA MESH (POLYPROPYLENE)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDICAL CORPORATION
• MDR Report Key: 22184899
• Report Number: MW5171293
• Device Sequence Number: 11810986
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/01/2025

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Death; Disability; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White