MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE; MESH, SURGICAL

Catalog Number	0608001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2021, for a mesh revision operation.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100549 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.As of 15 march 2023, of the (b)(4)devices released to finished goods for lot sp100549, 156 have been distributed with 62 reported as implanted.Based on our internal investigation with no remarkable findings, and 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.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.
Event or Problem Description
This is follow up#1 to report the results from the internal investigation and the conclusion.The aware date is based on when the batch record review was completed.As reported in the initial: it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6), 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6), 2021, for a mesh revision operation.
Event or Problem Description
This is follow up#2 to report that on (b)(6) 2023, pmqa received notification from legal that although a lot was provided in the original summons, the valid lot associated with this event was found through discovery and is sp100548-321.No other information was reported.As reported in initial: it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2021, for a mesh revision operation.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp100548 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE
• 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: 16512028
• Report Number: 1000306051-2023-00053
• Device Sequence Number: 12357947
• Product Code: FTM
• UDI-Device Identifier: 00818410010003
• UDI-Public: 00818410010003
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 06/30/2019
• Device Catalogue Number: 0608001
• Device Lot Number: SP100548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 06/13/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/17/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female