MAUDE Adverse Event Report: LIFECELL STRATTICE MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Disability (2371)

Event Date 01/01/2009

Event Type  Injury  

Event Description

I am a (b)(6) y/o male.It started with 1st surgery when they tried to install a few biological mesh in 2008 after a serous accident of motor vehicle.This lead to one year later another failure and was redone in 2009 same area of abdominal wall laparotomy incision umbilical abdominal type hernia repair, the second time ventral hernia repair with "strattice polly type mesh matrex".It failed again in (b)(6) 2010 and was incised sharply in a small area that was repaired again.This repair again failed causing more serious problems in (b)(6) 2011.Yet again more serious gross infections then lead to more incisional hernia repair with 20 x 25 cm large sheet with polypropylene proceed mesh.This also failed again later in which lead to more failure that stranger bowls and perforated it.Then they tried vicryl type mesh and vicryl sutures which all have failed me leading me to almost dying, now disabled handicap and wearing colostomy bags (multiply) i'm really messed up bad, i am a man and no one is helping me.I am left with stitches that keep getting infected and pushing through my skin bleeding causing severe pain.Please someone help me.I feel abandoned, my surgeon who performed my last surgery in fact scheduled me for date to take them out of me, then canceled in fear of making matters worse.

• Brand Name: STRATTICE MESH
• Type of Device: STRATTICE MESH
• Manufacturer (Section D): LIFECELL
• MDR Report Key: 7168793
• MDR Text Key: 96694424
• Report Number: MW5074429
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Weight: 66