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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN / LIFECELL CORP. STRATTICE BIOLOGICAL MESH MESH, SURGICAL

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ALLERGAN / LIFECELL CORP. STRATTICE BIOLOGICAL MESH MESH, SURGICAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240); Anxiety (2328); Deformity/ Disfigurement (2360); Depression (2361); Prolapse (2475)
Event Date 09/18/2014
Event Type  Injury  
Event Description
A strattice biologic mesh was implanted in (b)(6) 2014 due to abdominal hernia and stoma prolapse. Since (b)(6) 2014, the hernia and prolapsed stoma reoccurred 2 x's afterwards causing severe pain and add'l repair surgeries in 2015, and 2018 being scheduled currently. The strattice biological mesh in the repair surgeries was not removed for whatever reasons, but continue to cause problems because it is not supporting the abdominal wall to stop the hernia and stop the stoma from prolapse and reoccurring even though the site of the mesh was relocated and a new mesh placed. Hernia / prolapsed stoma are getting larger in each occurrence. Symptoms: severe pain, loss of appetite, abdominal disfigurement (hernia/stoma size of a grapefruit currently); depression and anxiety in rarely attended social occasions. I am a high risk pt with multiple chronic health issues and eventually due to this and my age (b)(6), i will be risking my life each time any surgery is performed in this stage of my life. If a repair surgery goes ignored, i risk hernia strangulation and/or intestinal blockage. I live in a world constrained to the seclusion of my home 95% of the time. The problem did not stop after the person reduced the dose or stopped taking using the product. The problem returned if the person started taking or using the product again.
 
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Brand NameSTRATTICE BIOLOGICAL MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ALLERGAN / LIFECELL CORP.
MDR Report Key7721793
MDR Text Key115209145
Report NumberMW5078619
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 07/23/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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: 07/25/2018 Patient Sequence Number: 1
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