FDA Adverse Event Injury Summary report: N

MARLEX MESH

MDR report key: 1022228 · Received March 28, 2008

Report

Report Number
MW5006080
Event Type
Injury
Date Received
March 28, 2008
Date of Event
February 10, 2006
Report Date
March 28, 2008
Product Code
FTL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MS, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE A CONCERN ABOUT THE HERNIA REPAIR MESH. I HAD MARLEX MESH PLACED ON MY ABDOMINAL WALL DUE TO MASSIVE HERNIA IN 2003. I HAD A TERRIBLE TIME HEALING HAD DEHISCED AND HAD TO BE DEBRIDED 3 TIMES DURING 2003. HAD A HOLE UNTIL 2003. AT THAT TIME, I WAS DEBRIDED AND FLAPPED CLOSED, HAD TO GO THROUGH A HYPERBARIC CHAMBER TO HELP HEAL. REMAINED CLOSED UNTIL 2005. I BEGAN HAVING A FEVER AND CHILLS IN THREE MONTHS EARLIER, HAD SEVERAL TESTS RUN, BLOOD WORK. IN 2005, I WENT TO AN EMERGENCY ROOM RUNNING 102.3 FEVER. MY BODY SMELLED WINEY, COULDN'T GO ANY FURTHER. I WAS ADMITTED. THEY RAN TESTS FOR A COUPLE OF DAYS, FOUND AN ABSCESS AGAINST MY ABDOMINAL WALL, INSTALLED A DRAIN AFTER TESTING THE FLUID. REFERRED ME BACK TO MY SURGEON. HE OPENED ME THREE MONTHS LATER, WAS PUT ON A SKY BLUE WOUND VAC UNTIL 2006. ANOTHER SURGEON HAD TO REMOVE MY MARLEX MESH AND SCAR TISSUE. I WENT HOME AND THE INCISION LINE, HALF, HAD TO BE OPENED AGAIN AND RECLOSED. DURING THESE SURGERIES, I HAD MRSA - STAPH - AND SEVERAL OTHER THINGS. I CAN'T REMEMBER ALL THE BACTERIA THAT GREW IN ME. SINCE ALL OF THIS, I CAN'T STAND FOR HARDLY ANY TIME, HAVE TROUBLE, MY LEGS ARE SWELLING. NEVER HAD THIS BEFORE. CAN'T GET DISABILITY BECAUSE I AM NOT OLD ENOUGH. CAN'T CONTINUE WITH THE TYPE OF WORK I WAS DOING SO I AM MAKING A LOT LESS MONEY. I JUST WANT TO KNOW IF THE RECALL INCLUDES THIS MESH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MARLEX MESH NONE FTL

Patients

Seq Age Sex Outcome Treatment
1 40 YR Required Intervention