MAUDE Adverse Event Report: LIFECELL SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1); MESH, SURGICAL

Catalog Number	CON1006
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported as serious injury due to the reported capsular contracture, baker grade iii with planned surgical intervention.The related report for the second strattice piece will be submitted with abbvie identifier (b)(6).A review of the device history record for strattice lot sp200010 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 strattice and this event could not be determined.If additional information is made available, a supplemental report will be submitted.
Event or Problem Description
Healthcare professional reported via medical information that a patient implanted with breast implants and strattice developed a second capsular contracture in both breasts and higher than the left.This record represents the right side strattice device.Healthcare professional later reported "grade 3 cap con right breast." this record represents 1 of 2 strattice devices.

• Brand Name: SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1)
• 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: 24122577
• Report Number: 1000306051-2026-00006
• Device Sequence Number: 20352475
• Product Code: FTM
• UDI-Device Identifier: 00818410010263
• UDI-Public: (01)00818410010263(10)SP200010(11)181010(17)200630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 06/30/2020
• Device Catalogue Number: CON1006
• Device Lot Number: SP200010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2018
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic
• Patient Race: White