MAUDE Adverse Event Report: LifeCell Medium Curved Shape for Strattice, BPS (Contour2); Mesh, Surgical

Catalog Number	CON2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported as serious injury due to the reported "infection" with surgical intervention.A review of the device history record for strattice lot sp300149 has been initiated.Further information from the reporter regarding the event and patient details has been requested.No additional information is available at this time.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.
Event or Problem Description
Healthcare professional reported via sales representative that a patient developed "an infection and "[strattice]" didn¿t incorporate." patient "was taken back" for revision surgery.

• 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 ; +1(847)936-6324
• MDR Report Key: 25037973
• Report Number: 1000306051-2026-00040
• Device Sequence Number: 21435237
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: (01)00818410010270(10)SP300149(11)250327(17)270228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Catalogue Number: CON2006
• Device Lot Number: SP300149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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: 57 YR
• Patient Sex: Female