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

Catalog Number CL1097P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Healthcare professional reported via sales representative that patient "presented in the er over the weekend with swelling, tenderness, redness, discolored discharge in [their] axillary drain." "fluid tested positive for serratia bacteria." the two artia tissue grafts were explanted from the right breast.This record is for graft 2 of 2.This is the same event and the same patient reported under abbvie complaint # (b)(4).

Manufacturer Narrative

This event is being reported as serious injury due to the reported infection and purulent discharge with surgical intervention.A review of the device history record for artia lot up200135 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the artia and this event could not be determined.If additional information is made available, a supplemental report will be submitted.

• Brand Name: ARTIA RECONSTRUCTIVE TISSUE MATRIX, CONTOUR LARGE, PERFORATED
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18944072
• MDR Text Key: 338157380
• Report Number: 1000306051-2024-00077
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CL1097P
• Device Lot Number: UP200135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female