MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE RECONSTRUCTIVE TISSUE MATRIX; MESH, SURGICAL

Model Number 1620002

Device Problems Contamination (1120); Patient-Device Incompatibility (2682)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

Male patient underwent simultaneous liver-kidney transplant.Multiple returns to operating room for complications.Strattice mesh placed ten days after to close abdominal wall.This case and another post-transplant/mesh case are possible mesh device infections.Operating room cultures grew multidrug resistant organisms (mdro) and fungus.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL CORPORATION; 4 millenium way; branchburg NJ 08876
• MDR Report Key: 15371998
• MDR Text Key: 299410990
• Report Number: 15371998
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1620002
• Device Catalogue Number: 1620002
• Device Lot Number: SP200295-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 70 KG