MAUDE Adverse Event Report: LIFECELL STRATTICE PERFORATED 16 X 20; MESH, SURGICAL

Catalog Number	1620002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to lifecell for evaluation.The internal investigation into strattice lot sp100613 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, (b)(4) devices were released to finished goods and (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined.Other surgical or patient factors could also contribute to this event.No further actions are required as a nonconformance could not be confirmed.
Event or Problem Description
Healthcare professional reports primary ventral hernia repair with strattice mesh (material #: 1620002p, serial #: (b)(4)).Patient experienced chronic abdominal wall abscess, infected unincorporated mesh.Product explanted 6 months later.

• Brand Name: STRATTICE PERFORATED 16 X 20
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• MDR Report Key: 11259134
• Report Number: 1000306051-2021-00002
• Device Sequence Number: 2529830
• Product Code: FTM
• UDI-Device Identifier: 00818410012298
• UDI-Public: 00818410012298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: 02/11/2020
• Device Catalogue Number: 1620002P
• Device Lot Number: SP100613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention