MAUDE Adverse Event Report: LIFECELL ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR SMALL, PERFORATED; MESH, SURGICAL

Catalog Number	CS1097P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.This is a known potential adverse event addressed in product labeling.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
Healthcare professional reported that a clinical patient that was implanted with artia has experienced infected seroma in the left breast.The following actions have been taken: seroma aspirated for turbid seroma, culture sent, and seroma catheter placed.Keflex oral antibiotic has been given as a treatment.Symptoms have been resolved.It was confirmed later that both lot numbers up200128-112, and up200133-274 were used on the left breast in the original implant.This is the same patient reported under patient identifier (b)(6).This emdr is being submitted for the lot # up200128-112.

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR SMALL, PERFORATED
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: terry ingram ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 23020090
• Report Number: 1000306051-2025-00087
• Device Sequence Number: 9769535
• Product Code: FTM
• UDI-Device Identifier: 00818410014476
• UDI-Public: (01)00818410014476(10)UP200128(11)230706(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 05/31/2025
• Device Catalogue Number: CS1097P
• Device Lot Number: UP200128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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: Female