MAUDE Adverse Event Report: LIFECELL STRATTICE PORCINE BIOLOGICAL SURGICAL MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Scar Tissue (2060); Vomiting (2144); Tooth Fracture (2428); No Code Available (3191)

Event Date 09/24/2013

Event Type  Injury  

Event Description

Late (b)(6) 2013, after receiving treatment for rectal cancer, i was admitted to (b)(6) for removal of the tumor.(a/p resection).During the operation by dr.(b)(6), lifecell's strattice porcine mesh was used.I was admitted to icu for what was supposed to be about 3 days.During my time there, i began to violently vomit bile.After 10-11 days, i was finally released, just to be readmitted, by dr.(b)(6), 2 weeks later for same problem.Four days later i was released, to once again be admitted via the emergency room, after a ct was performed, for once again the same problem.The difference this time was a ct was done and indicated the mesh had failed, i had built up scar tissue along the mesh, and there was 3 bowel blockages.A 2nd surgery was performed to remove the majority of the failed mesh unblock the bowel and lysis of adhesions.I continue to have irregular bowel movements and severe abdominal pain.I am now unable to obtain an erection and my teeth have been decaying and falling out in spite of my best dental hygiene attempts to avoid the problem.

• Brand Name: STRATTICE PORCINE BIOLOGICAL SURGICAL MESH
• Type of Device: STRATTICE PORCINE BIOLOGICAL SURGICAL MESH
• Manufacturer (Section D): LIFECELL
• MDR Report Key: 6900185
• MDR Text Key: 87786784
• Report Number: MW5072517
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• 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 Age: 53 YR
• Patient Weight: 77