MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number	CON3006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Capsular contracture is a documented complication associated with this type of surgical procedure with or without the use of an adm (acellular dermal matrix).Internal investigation into lot sp200344 revealed no remarkable findings, including (b)(4) devices distributed with no other complaints reported against the lot and no deviations or nonconformances revealed during processing with product or patient impact.Based on the results of the investigation, and the patient's history of capsular contracture from the previous complaint, the event is unlikely related to the strattice.Lot sp200344 was terminally sterilized and met all qc release criteria.
Event or Problem Description
It was reported from the sales rep on behalf of the customer that a patient previously implanted with strattice who had a complaint of capsular contracture on the right breast, now developed grade 4 capsular contracture on the left breast.The hcp is planning to remove and implant 2 new pieces on her left side in july.The patient also has mentor silicone gel implants.The previous complaint for the right breast is documented under (b)(4) mdr# 1000306051-2023-00020.This record is associated with her left breast, lot sp200344-150.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• 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: 17201163
• Report Number: 1000306051-2023-00135
• Device Sequence Number: 6667153
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 10/31/2023
• Device Catalogue Number: CON3006
• Device Lot Number: SP200344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREAST IMPLANT - (B)(6) 2022
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown