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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE MESH

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LIFECELL STRATTICE MESH Back to Search Results
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.
 
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Brand NameSTRATTICE MESH
Type of DeviceSTRATTICE MESH
Manufacturer (Section D)
LIFECELL
MDR Report Key7168793
MDR Text Key96694424
Report NumberMW5074429
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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