MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2); MESH, SURGICAL

Catalog Number	CON2006
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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.A review of the device history record for strattice lot sp200323 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 a sales representative that patient has "a recurrent capsular contracture with the use of strattice." "the patient presented to [the surgeon] with a cap con from a previous surgery." "the surgeon switched out the patients implants, changed the plane from above the muscle to below the muscle and used strattice on both sides." the surgeon saw the patient "this week and [they have] grade 3 cap con again on the right side." a reoperation has been scheduled.The device remains implanted.This record is associated with the strattice graft implanted in the right breast.
Additional Manufacturer Narrative
Additional, changed, and/or corrected fields: b.1, b.2, b.5, h.1, h.6.This report is being filed to un-report the event of capsular contracture, baker grade iii as it is no longer reportable to fda.This report concludes our investigation.
Event or Problem Description
Healthcare professional reported via the sales representative that the strattice device did not cause or contribute to the event of capsular contracture, baker grade iii "as the patient already had cap con before strattice was implanted." this report is being filed to un-report the event as it is no longer reportable to fda.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• 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: 24123127
• Report Number: 1000306051-2026-00007
• Device Sequence Number: 9335064
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: (01)00818410010270(10)SP200323(11)210823(17)230630
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 06/30/2023
• Device Catalogue Number: CON2006
• Device Lot Number: SP200323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2021
• 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 Age: 71 YR
• Patient Sex: Female