FDA Adverse Event Injury Summary report: N

SOFT MESH

MDR report key: 3840209 · Received May 22, 2014

Report

Report Number
MW5036339
Event Type
Injury
Date Received
May 22, 2014
Date of Event
April 9, 2012
Report Date
May 21, 2014
Manufacturer
DAVOL INC BARD
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WENT THROUGH SOME UNFORTUNATE SITUATIONS WHEN I LIVED IN (B)(6) THAT I WANTED TO EXPRESS TO YOU. I UNDERWENT MAJOR SURGERY IN (B)(6) 2012, FOR A STOPPA HERNIA REPAIR (IN ADDITION TO THAT I HAD A TUMMY TUCK, A SYNTHETIC MESH IMPLANT, AND AN UMBILICOPLASTY). I WAS DIAGNOSED WITH DIASTASIS RECTI AND ACCORDING TO SURGEON DR (B)(6), THIS WAS THE BEST PROCEDURE FOR MY DIAGNOSIS. I STAYED IN THE HOSP FOR 6 DAYS. I WAS NOT FEELING WELL AND SUFFERED A FEW MISHAPS WHILE I WAS IN THE HOSP. AFTER I WAS HOME, FOR THE NEXT FEW WEEKS I DID NOT FELL LIKE I WAS IMPROVING. I HAD MY POST SURGERY APPOINTMENT (B)(6) 2012 AND SPOKE TO DR (B)(6) REGARDING MY CONCERNS. DR ADVISED TO GIVE IT SOME TIME. IT WAS MAJOR SURGERY AND THESE THINGS TAKE TIME TO HEAL. I CONTINUED WITH PAIN AND LOTS OF DISCOMFORT. ON (B)(6) 2012, I MADE ANOTHER APPOINTMENT WITH DR (B)(6) TO QUESTION HIM WHY I HAD THESE SYMPTOMS AND WHY WAS THE APPEARANCE OF MY STOMACH THE WAY IT WAS. DURING THIS TIME I VISITED QUITE A FEW GENERAL SURGEONS AS WELL AS PLASTIC SURGEONS. FOR THE MOST PART, THEY ALL HAD THE SAME CONCLUSION, NOT REALLY SURE WHAT HAPPENED AND TO GIVE HEALING TIME. ON (B)(6) 2012, I ASKED DR WHAT WAS GOING ON, WHY I FELT THE WAY I DID, AND WHY DID I LOOK THE WAY I DID. DR (B)(6) SAID TO UNDERSTAND THAT THIS WAS MAJOR SURGERY AND WHAT I HAD IN MY ABDOMEN WAS FLUID AND THAT WITHIN 3 MONTHS MY BODY WILL ABSORB IT. I CONTINUED MY RESEARCH. I REQUESTED MY MEDICAL REPORTS AND REALIZED THAT DR (B)(6) DID NOT NOTATE WHAT WE SPOKE THE LAST TIME I SAW HIM ((B)(6) 2012). WHEN I CALLED (B)(4), I WAS TOLD HE UNEXPECTEDLY LEFT THE COUNTRY. THEY WERE NOT SURE WHY BUT HE WAS NOT THERE. I WAS VERY NERVOUS AND COULD NOT BELIEVE WHAT I WAS HEARING. I CONTINUED VISITING DIFFERENT SURGEONS UNTIL FINALLY I WENT BACK TO (B)(4). I SPOKE TO DR (B)(6) AND HE REFERRED ME TO PAIN MANAGEMENT. THE LEFT SIDE OF MY ABDOMEN HAD DAMAGED NERVES AND THIS IS ALL HE CAN HELP ME WITH. I DID ATTEMPT PAIN MANAGEMENT BUT DID NOT FEEL COMFORTABLE WITH THE INFO GIVEN TO ME. I WAS REFERRED BY MY PRIMARY PRACTIONER TO DO PHYSICAL THERAPY. AFTER 30 DAYS, THEY EVALUATED ME AND WERE NOT ABLE TO DO ANYMORE FOR MY CONDITION. I DID IMPROVE ON CERTAIN ASPECTS BUT NOT THE PAIN I FELT. I DECIDED TO GO BACK TO (B)(4) AND SAW DR (B)(6). BOTH EVALUATED ME AND WOULD DECIDE IF THEY WOULD HELP MY SITUATION. AFTER 2 MONTHS OF WAITING, I FINALLY GOT A RESPONSE THAT THEY WILL REMOVE THE MESH AND HAVE A SECOND TUMMY TUCK DONE. ON (B)(6) 2013, I GOT MY SURGERY DONE. ALTHOUGH, THE APPEARANCE OF MY ABDOMEN IS SMOOTHER WITH NO BELLY BUTTON I STILL FELL LOTS OF DISCOMFORT. I RECENTLY HAD A CT SCAN DONE AND IT SHOWS MODERATE ABDOMINAL DISTENTION AND URINARY BLADDER DISTENTION. WHICH EXPLAINS MY DISCOMFORTS AND COMPLICATIONS. I WAS BASICALLY TOLD THAT WITHIN 12 WEEKS OF RECOVERY, HOWEVER, MY BODY LOOKS AND RESPONDS IS WHAT I WILL LIVE WITH FOR THE REST OF MY LIFE. PAIN MANAGEMENT WOULD BE MY NEXT BEST CHOICE. MED WATCH MEMBERS, EMOTIONALLY, PHYSICALLY, AND MY FAMILY LIFE HAS BEEN GREATLY AFFECTED. NO ONE CAN GIVE ME THAT BACK. I HAVE ATTEMPTED TO FIND JUSTICE WITH MEDICAL MAL PRACTICE LAWYERS, AND UNFORTUNATELY MY CASE APPEARS COMPLICATED AND COSTLY. I SUFFERED WITH DR (B)(6) POOR STANDARD OF CARE. I HAVE DONE NUMEROUS COMPLAINTS WITH THE INSURANCE COMPANY I HAD AT THE TIME, (B)(4), IN THE FRAUDULENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
304529 SOFT MESH MESH FTL DAVOL INC BARD 280430 HUWA0773

Patients

Seq Age Sex Outcome Treatment
1 32 YR Hospitalization| R| S