FDA Adverse Event Injury Summary report: N

PROGRIP PARIETEX

MDR report key: 4192818 · Received October 16, 2014

Report

Report Number
MW5038700
Event Type
Injury
Date Received
October 16, 2014
Date of Event
September 21, 2012
Report Date
October 16, 2014
Manufacturer
COVIDIEN
Product Code
FTL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PROGRIP PARIETEX COVIDIEN WAS USED, FOR L/R BILATERAL INGUINAL AND UMBILICAL HERNIAS. THREE HERNIAS WERE REPAIRED LAPAROSCOPICALLY. PER 2 SMART DOCTORS AND A LOT OF RADIOLOGY, FROM DAY TWO THAT IS, THEY DAY AFTER MY SURGERY, THE MESH NEVER HELD. IT MOVED AND IS NOW STILL BUNCHED UP. WITH NO INSURANCE, I 100% HAVE PAID OUT OF MY POCKET FOR THIS SURGERY. SINCE THAT DATE, I HAVE SPENT (B)(6) OF MY SURGERY COST, IN AN EFFORT TO FIGURE OUT WHAT HAPPENED AND CONTINUES TO BE DONE TO ME AND MY BODY. I HAVE SO MANY BAD PROBLEMS FROM THE PROGRIP MESH, I CAN'T POST THEM ALL IN A SIMPLE EXPLANATION HERE. FOR ONE, ONE RADIOLOGY SHOWS NOW 2 YEARS LATER, MESH (MESH DOES NOT SHOW, IT'S INVISIBLE SO THE FACT IT SHOWS IN ULTRASOUNDS MEANS IT IS NOT IN PLACE ALSO) FROM MY BOTTOM OF MY LEFT INGUINAL CANAL UP TO 8 INCHES IN TO MY LEFT SIDE STOMACH, IS A SOLID AREA OF MESH AND SCAR TISSUE. OFTEN, A MUSHY LUMP AREA, CREATED AND CAUSED BY THE FACT THE MESH NEVER HELD. IT IS SQUEEZING 3-5 NERVES AND SPERM CORD AND ARTERY AND VEIN. IT HURTS EVERY DAY. THE FIRST 18 MONTHS POST OP I LAID IN BED IN AGONY. AGAIN, SINCE MY SURGERY, I HAVE SPENT MONEY OUT OF MY POCKET, THE SURGERY X 3, 300%, 200% SINCE THE SURGERY. THIS SURGERY HAS WRECKED ME AND KEPT ME FROM MAILING RESUMES OUT. WITH NO INSURANCE, I 100% MYSELF HAVE PAID FOR THE ENTIRE SURGERY AND ALSO ALL THE SURGEON AND UROLOGIST CONSULT VISITS AND CT AND ULTRASOUNDS AND ON AND ON. SINCE THE SURGERY, I HAVE SPENT A LOT OF MONEY. THE MESH HAS CAUSED SEX ISSUES, AGONY IN THE THIGH MUSCLES AND DOWN PAST BACKSIDE OF KNEE. A LOT OF MEN I READ ONLINE ALSO SUFFER FROM THIS. THE MESH MOVES THE "VELCRO" ON MY BODY, DOES NOT HOLD.... I HAVE NOT YET FOUND A SURGEON IN THIS STATE TO HELP ME. I THINK THESE ISSUES MAY BE CAUSED BY THE MESH: AN INCISIONAL HERNIA, MUSCLE HERNIA, SCROTAL HERNIA, ONLY MY GUESS. I HAVE REQUESTS FOR SURGICAL HELP OUT TO MANY SURGEONS IN MANY STATES AND 2 COUNTRIES. I NEED HELP. NO ONE WILL HELP ME, BUT ALL WILL TAKE MY GROCERY MONEY TO PAY FOR A CONSULT AND DO NOT A THING. JUST PAST 30 DAYS I SPENT A DOLLAR AMOUNT EQUAL TO A PERCENTAGE OF THE SURGERY COST, TO ATTEMPT TO FIGURE THIS OUT. THIS MESH NEEDS TO BE RECALLED AND BANNED. MANY MEN SUFFER AND REGARDLESS I DO. HELL ON EARTH IS AN UNDERSTATEMENT. THIS MESH IS A MENACE. AND THE "LIPOMA" THEY SAID, IS NO WAY IN "(PROFANITY)" A LIPOMA, NOT WITH MY SYMPTOMOLOGY. IT IS LIKELY AN INCISIONAL HERNIA OR MUSCLE HERNIA OR SCROTAL HERNIA. I HAVE A LOT OF PAPERWORK I CAN FAX, BUT WOULD NOT TO YOUR OFFICE. THE WAY IT WORKS IN THIS STATE IS BARBARIC, HELPING ME IS THEIR LAST INTEREST...ONLY SELL ANOTHER SURGERY FOR HERNIAS. LATE 2012 WAS SURGERY. THIRTY-FOUR MINS OUTPATIENT AT A HOSP, A FRIEND WAS WITH ME THROUGH THE ENTIRE SURGERY. NO TIRES FOR MY TRUCK. NO ONE REVIEWS AVAILABLE MESHES AND TELLS THE SURGEON " I WANT (B)(6)." NOT FAIR THAT THIS MESH IS STILL ALLOWED TO BE PUT INSIDE ANY MAN'S BODY. NOTE I AM SINGLE (AGAIN) AND NEVER BEEN A DAD. I WILL HAVE CHILDREN MY SEED. THIS IS "(PROFANITY)". AM I UPSET? NO, THAT WAS 1.5 YEARS AGO. AFTER A LOT OF POST OP VISITS BEING TOLD "ALL IS WELL" I AM SICK OF HEARING THAT LINE OF BULL CRAP. NOT ONLY DOES THIS HAVE SEXUAL EFFECTS BIG TIME ON MY BODY, AND MY STOMACH ACHES FROM THE MESH, IT FEELS LIKE A MONKEY GRIP ON MY THIGH MUSCLES. THE MESH IS HORRIBLE NOT ONLY EXCELLENT BACKGROUND UROLOGIST OR SURGEON (SEEN AND PAID 4 OF EACH AND MOST THE PAST 45 DAYS) HAS ANY INPUT. A MEDICAL LOAN IS 20% APR INTEREST. TO HAVE THE "NEWLY MESH CAUSED (B)(6) 2012 HERNIA? TYPE" REMOVED AND OR LIPOMA AND HERNIA REVISION DONE. I WILL NEED A LOAN TO BUY 2 MORE SURGERIES WHEN I FIND A REAL SURGEON IN SOME STATE OR COUNTRY TO HELP ME. I WAS IN NEAR OLYMPIC CONDITION PHYSICALLY AND CAN PROVE THAT WITH ALL THE ANIMAL RESCUE AND ADOPTION LARGE EVENTS I HELPED VOLUNTEER TO PUT ON-- AND FOLKS I HAVE KNOWN 10+ YEARS WOULD TELL YOU "(B)(6) CAN LIFT AND RUN AND DO ANYTHING." IT IS HARD TO RUN. THIS MESH MOVED AND BUNCHED UP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
659775 PROGRIP PARIETEX HERNIA MESH FTL COVIDIEN

Patients

Seq Age Sex Outcome Treatment
1 58 YR Other| S