MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from the sales rep on behalf of the hcp that reported a strattice 20x25cm was previously implanted in a bridge/inlay fashion.As per the hcp, ¿the strattice at the fascia margins looked great and fixated and what was present thru the center had grown into the bowel and was thinned, then separated and pulled of a section of small bowel causing a leak.¿ no other information was reported.
Additional Manufacturer Narrative
Based on the provided information, review of the lot processing history with no deviations in association with the event and no other complaints reported against the lot, the event is unlikely related to the device.Adhesion formation is a known post-operative surgical complication independent of the use of a mesh.Patient factors of obesity and prior abdominal surgeries may have contributed to the event.The lot met qc criteria for product release.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 16638502
• Report Number: 1000306051-2023-00069
• Device Sequence Number: 6727098
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 2025002
• Device Lot Number: SP200404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown