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	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.10 continued related report number: 1000306051-2025-00032.A review of the device history record for strattice lot sp200337 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.A relationship between the strattice and this event could not be conclusively determined.If additional information is made available, a supplemental report will be submitted.
Event or Problem Description
Healthcare professional reported that patient had right side breast implant with strattice implanted.The patient then suffered "infection and extrusion" of the implant.On re-operation, the tissue was noted to be "partially dissolved." this record is for the strattice tissue graft.The related breast implant was previously reported under mrn 9617229-2022-17949 (abbvie complaint number: (b)(4).Pmqa received a communication from fda cber regarding related report mrn: 1000306051-2025-00032 (abbvie complaint number: (b)(4) reporting additional information provided by the surgeon on (b)(6) 2025.The surgeon reported patient "had replacement of bilateral implants with capsulectomies and strattice slings on (b)(6) 2025." the surgeon provided lot numbers which were for strattice tissue.Therefore, it is assumed that the patient had strattice tissue implanted and not alloderm.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• 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: 22012994
• Report Number: 1000306051-2025-00052
• Device Sequence Number: 5342692
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: (01)00818410010294(10)SP200337(11)211117(17)230930
• Combination Product (Y/N): N
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 09/30/2023
• Device Catalogue Number: CON3006
• Device Lot Number: SP200337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 11/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female