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

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.

• Brand Name: STRATTICE BIOLOGICAL MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ALLERGAN / LIFECELL CORP.
• MDR Report Key: 7721793
• MDR Text Key: 115209145
• Report Number: MW5078619
• 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: 07/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• 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