FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 2223029 · Received August 16, 2011

Report

Report Number
MW5021840
Event Type
Injury
Date Received
August 16, 2011
Date of Event
October 17, 2008
Report Date
August 16, 2011
Manufacturer
UNK
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE PLEASURE OF MEETING MR. (B)(6) IN CONSULTATION TODAY. HE IS A (B)(6) OLD GENTLEMAN WHO HAD COLONOSCOPY ROUGHLY FIVE YEARS AGO. WHICH REVEALED DIVERTICULOSIS. SUBSEQUENT TO THIS, HE DEVELOPED INTERMITTENT EPISODES OF DIVERTICULITIS. IN (B)(6) 2008. HE HAD AN EPISODE OF DIVERTICULITIS, WHICH REQUIRED SURGICAL INTERVENTION. AT THAT TIME, HE HAD A PRIMARY ANASTOMOSIS, WHICH SUBSEQUENTLY LEAKED. HE DEVELOPED PERITONITIS FROM THIS AND HAD A SECOND SURGERY, WHICH LEFT HIM WITH A COLOSTOMY. THE SURGERY WAS AS HARTMANN SURGERY. HE HAD THIS HARTMANN REVERSED IN (B)(6) 2009. IN (B)(6) 2009, HE HAD AN INCISIONAL HERNIA, WHICH WAS REPAIRED. THIS WAS PERFORMED AT SCRANTON HOSPITAL WHERE A MESH WAS PLACED. SINCE THE SURGERY, HE HAS HAD BURNING, PULLING, TETHERING PAIN EMANATING FROM THIS SITE. IN (B)(6) 2010, HE DEVELOPED A SMALL BOWEL OBSTRUCTION DUE TO SMALL BOWEL TETHERING TO THIS MESH. HE UNDERWENT LAPAROSCOPY. WHICH REVEALED SMALL BOWEL OBSTRUCTION WITH A FOCAL POINT NEAR THIS MESH WORK. SINCE SURGERY, HE HAS CONTINUED TO HAVE DEBILITATING ABDOMINAL PAIN. HE ALSO DEVELOPS PAIN, BLOATING AND DISTENTION AFTER HE EATS. IF HE WERE TO SIT FOR A LONG PERIOD OF TIME, THE MESH IS IRRITATING TO HIS ABDOMINAL MUSCULATURE. HE DEVELOPS RARE GASTROESOPHAGEAL REFLUX WITHOUT DYSPHAGIA OR ODYNOPHAGIA. HE HAS TRIED PHYSICAL THERAPY WITH NO RELIEF. HE IS CURRENTLY SEEING PAIN CLINIC, WHICH IS MILD TO MODERATELY HELPING HIS PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN UNKNOWN MESH FTL UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 55 YR Hospitalization| O| R| S