MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM; MESH, SURGICAL

Catalog Number	2020002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a legal event that a 67 year old male patient had hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2021, for a revision surgery.No other information was reported.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp100441 has been initiated.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.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up#1 to report on 7/20/2023, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100441-177.No other information was reported.As reported in the initial: it was reported from a legal event that a 67 year old male patient had hernia repair surgery on or about (b)(6) 2017.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2021, for a revision surgery.No other information was reported.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
• 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: 16691273
• Report Number: 1000306051-2023-00085
• Device Sequence Number: 5921535
• Product Code: FTM
• UDI-Device Identifier: 00818410010140
• UDI-Public: 00818410010140
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 07/31/2018
• Device Catalogue Number: 2020002
• Device Lot Number: SP100441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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: 67 YR
• Patient Sex: Male