MAUDE Adverse Event Report: LifeCell Large Curved Shape for Strattice, BPS (Contour3); Mesh, Surgical

Catalog Number	CON3006
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(847)936-6324
• MDR Report Key: 50743222
• Report Number: 1000306051-2026-00074
• Device Sequence Number: 21387703
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: (01)00818410010294(17)171231(10)SP100342
• 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: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 12/31/2017
• Device Catalogue Number: CON3006
• Device Lot Number: SP100342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2016
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 140 LB
• Patient Race: White