MAUDE Adverse Event Report: LIFECELL UNKNOWN ARTIA; MESH, SURGICAL

Catalog Number UNK ARTIA

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Article citation: 'implant-based breast reconstruction with artia tissue matrix' b.Fakim, l.Highton and a.Gandhi et al., implant-based breast reconstruction with artia tm tissue matrix, journal of plastic, reconstructive & aesthetic surgery, https://doi.Org/10.1016/j.Bjps.2019.05.024.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The reason for reoperation: seroma, infection, necrosis.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Article reports 6 breasts developing seromas requiring aspiration, 1 breast developing a haematoma and 2 implant losses due to necrosis and infection.It is unknown if the device remains implanted.

• Brand Name: UNKNOWN ARTIA
• Type of Device: 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 ; 9089471100
• MDR Report Key: 8821162
• MDR Text Key: 152025230
• Report Number: 1000306051-2019-00095
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARTIA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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