MAUDE Adverse Event Report: SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1); MESH, SURGICAL

Catalog Number	CON1006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported from the sales rep on behalf of the hcp that strattice device lot was (b)(4), con1006 was explanted, may have been in august.The sales rep was unsure if it was an infection.No other information was provided.The complaint related device was discarded.Clarification was received that the lot associated with this event is sp200131-304.Updated information was received on 10/jan/2023, that the strattice was implanted on (b)(6) 2020.The l drain and more drainage than the r and the l drain was removed (b)(6) 2020.After the drain removal the patient had intermittent drainage from the l breast from (b)(6) 2020 to (b)(6) 2021.The l breast was swollen and tender.The implant was removed on (b)(6) 2021 and pathology of the strattice was taken.The hcp does believe the infection was due to the strattice.
Additional Manufacturer Narrative
Based on the internal investigation into lot sp200131 with no remarkable findings, including (b)(4) devices distributed with no other related complaints reported against the lot and no related deviations or nonconformances revealed during manufacturing, strattice as a contributing factor to the event cannot be ruled out, thus this event was reported to the fda as serious injury.Lot sp200131 was terminally sterilized and met all qc release criteria.It was reported the hcp indicates a relationship between the strattice and the infection.As indicated in the instructions for use, infection is a potential adverse event associated with implantation procedures where surgical mesh materials are use.No further actions are required, no device nonconformances were confirmed.

• Brand Name: SMALL CURVED SHAPE FOR STRATTICE, BPS (CONTOUR 1)
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 16151932
• Report Number: 1000306051-2023-00003
• Device Sequence Number: 15330290
• Product Code: FTM
• UDI-Device Identifier: 00818410010263
• UDI-Public: 00818410010263
• 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: 2020
• Device Explanted Year: 2021
• 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): 01/12/2023

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: 06/30/2021
• Device Catalogue Number: CON1006
• Device Lot Number: SP200131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/12/2023
• 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: IMPLANTS (B)(6) 2020- (B)(6) 2021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female