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

Catalog Number UNK STRATTICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Capsular Contracture (1761)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

Article citation: wilson rl, kirwan cc, o'donoghue jm, linforth ra, johnson rk, harvey jr.The long-term outcomes of the browse multicentre cohort study comparing strattice¿-assisted implant based reconstruction and submuscular reconstruction [abstract].In: proceedings of the 2018 san antonio breast cancer symposium; 2018 dec 4-8; san antonio, tx.Philadelphia (pa): aacr; cancer res 2019;79(4 suppl):abstract nr p5-16-03.The event of capsular contracture baker grade unknown is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reason for reoperation: capsular contracture baker grade unknown.Further information from the reporter regarding event, product, or patient details will not be requested as contact information was not provided.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Through journal article ¿the long-term outcomes of the browse multicentre cohort study comparing strattice¿-assisted implant based reconstruction and submuscular reconstruction,¿ the event of patients in strattice group experienced capsular contracture, baker grade unknown, and 7% of those patients underwent surgical intervention was reported.

• Brand Name: UNKNOWN STRATTICE
• 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: 8731588
• MDR Text Key: 149100815
• Report Number: 1000306051-2019-00082
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• 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