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	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from the sales rep on behalf of the hcp that they have a patient who developed capsular contracture with strattice lot: sp200354-085 implanted on (b)(6) 2022.They are removing and implanting a new piece.No other information was provided.Additional information was received on 18/jan/2023 that the patient underwent breast augmentation with placement of silicone gel implants.There was firmness on right breast noted on 5 months later, 7 months grade 4 capsular contracture noted.Treatment included right breast removal and replacement of silicone gel implant, 2 pieces of adm.It was noted the patient has a previous history of capsular contracture.
Additional Manufacturer Narrative
Capsular contracture is a documented complication associated with this type of surgical procedure with or without the use of an adm (acellular dermal matrix).Based on the internal investigation into lot: sp200354 with no remarkable findings, including (b)(4) devices distributed with no other complaints reported against the lot and no deviations or nonconformances revealed during processing with product or patient impact, the event is unlikely related to the strattice.Lot: sp200354 was terminally sterilized and met all qc release criteria.It was reported there was possibly a relationship between strattice and the event as per the surgeon.Strattice as a contributing factor to the event cannot be ruled out.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 16268910
• Report Number: 1000306051-2023-00020
• Device Sequence Number: 17772681
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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: 11/30/2023
• Device Catalogue Number: CON3006
• Device Lot Number: SP200354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREAST IMPLANTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown