FDA Adverse Event Injury Summary report: N

BARD MESH

MDR report key: 2132677 · Received June 13, 2011

Report

Report Number
MW5020996
Event Type
Injury
Date Received
June 13, 2011
Date of Event
June 17, 2003
Report Date
June 13, 2011
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2003, I HAD A UMBILICAL HERNIA AND A INGUINAL HERNIA REPAIRED WITH BARD MESH MONOFILAMENT POLYPROPYLENE REF# (B)(4) LOT #43HMD027. SHORTLY AFTER SURGERY, I WENT TO SEE DR (B)(6) ABOUT A HARD LUMP, SWELLING AND CONSTANT PAIN. HE SAID THE LUMP WAS DUE TO THE MESH BECOMING "ROLLED UP" AND THAT HE COULD FIX IT. MEANWHILE, AS I WAS CONSIDERING THIS, I BECAME MORE SICK, STOMACH ISSUES, SWELLING, CONSTIPATION, DIARRHEA, NAUSEA AND A FEVER. I WENT TO MY PRIMARY CARE AND HE TRIED DIFFERENT THINGS, FOR ABOUT 8 WEEKS, I WAS SICK IN BED AND THEN IT LEVELED OFF. AS TIME WENT ON, I JUST DEALT WITH HOW MY LIFE WAS GOING TO BE. I COULD NOT SIT FOR LONG PERIODS, DRIVING WAS VERY PAINFUL, STABBING PAIN, EATING DINNER OR SITTING FOR MORE THAN 10 MINS IS NOT DOABLE. I HAD ALL SORTS OF MEDICAL TESTS DONE TO SEE WHAT IT COULD BE ... UPPER GI, COLONOSCOPY, MRI, CAT SCAN, DURING THIS PROCESS, WE FOUND RENAL CELL CARCINOMA, I HAD THIS REMOVED ON (B)(6) 2007. BUT MY PAIN, SWELLING WAS NOT HEALED. ON (B)(6) 2008, DR (B)(6) WENT IN TO FIX WHAT WAS THOUGHT TO BE A HERNIA BUT IT WAS A SUTURE GRANULOMA AROUND THE MESH AREA. I HAVE A NEW SPOT WHICH MAYBE THE SAME THING. I AM STILL IN SEVERE PAIN, SWELLING, EDEMA, ALL ABDONIMAL DISTRESSES. I CANNOT SIT, DRIVE, TRAVEL, STAND FOR ANY LENGTH. MY LIFE IS A CONSTANT STATE OF PAIN, I HAVE TRIED PT SEVERAL TIMES, I WEAR BINDERS TO HELP WITH ACTIVITY AND I HAVE TRIED PAIN MEDS BUT NONE WORKS. I HAVE READ MANY POSTS AS TO OTHERS WITH SIMILAR ISSUES AND OTHER RECALLED ITEMS WITH BARD, CAN MINE BE A PART OF THIS??

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE 3X6 FTL 43HMDO27

Patients

Seq Age Sex Outcome Treatment
1 42 YR Other| R