MAUDE Adverse Event Report: 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	Cellulitis (1768)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp200334 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.
Event or Problem Description
Limited information was reported on 15/sep/2022 from the sales rep on behalf of the hcp that they had a patient who had surgery on (b)(6) 2022 with strattice and she ended up having an implant exchange and had her strattice removed on (b)(6) 2022 d/t cellulitis.The lots associated with this event were reported as right breast: (b)(4) and left breast: (b)(4).This record is associated with right breast: (b)(4).Refer to mdr 1000306051-2022-00165 for the left breast investigation.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15539360
• Report Number: 1000306051-2022-00167
• Device Sequence Number: 6962841
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 10/04/2022

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: 09/30/2023
• Device Catalogue Number: CON2006
• Device Lot Number: SP200337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREAST IMPLANTS 5/4/2022-
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown