MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/28/2020
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) 2019.During hernia repair surgery, the surgeon implanted a strattice mesh.The records indicate the device was a strattice mesh.Patient had a subsequent strattice mesh implanted during a hernia repair surgery on (b)(6) 2020.The records indicate the device was a strattice mesh.Patient underwent a revision surgery on (b)(6) 2021.This record is for the 1st strattice mesh.No other information was provided.This is the same event and the same patient reported under mdr # 1000306051-2023-00026 (allergan complaint # (b)(4).
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
The lot associated with this event was found through discovery and is sp100567-015.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 on 11/may/2023, pmqa received notification from legal that the lots associated with this event were found through discovery and are sp100567-015, implant date (b)(6) 2019 and sp200083-376, implant date (b)(6) 2020.No other information was reported.As reported in the initial: "it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2019.During hernia repair surgery, the surgeon implanted a strattice mesh.The records indicate the device was a strattice mesh.Patient had a subsequent strattice mesh implanted during a hernia repair surgery on (b)(6) 2020.The records indicate the device was a strattice mesh.Patient underwent a revision surgery on (b)(6) 2021.This record is for the 1st strattice mesh.".
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100567 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 (b)(6)2023, all of the (b)(4) devices released to finished goods for lot sp100567 were distributed.Of the (b)(4) distributed, (b)(4) have been 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#2 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 follow up#1: "on 11/may/2023, pmqa received notification from legal that the lots associated with this event were found through discovery and are sp100567-015, implant date (b)(6)2019 and sp200083-376, implant date (b)(6) 2020.No other information was reported." as reported in the initial: "it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2019.During hernia repair surgery, the surgeon implanted a strattice mesh.The records indicate the device was a strattice mesh.Patient had a subsequent strattice mesh implanted during a hernia repair surgery on (b)(6) 2020.The records indicate the device was a strattice mesh.Patient underwent a revision surgery on (b)(6)2021.This record is for the 1st strattice mesh.".

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, 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: 16250968
• Report Number: 1000306051-2023-00025
• Device Sequence Number: 5400408
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• 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: 2019
• 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

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: 08/31/2019
• Device Catalogue Number: 2025002
• Device Lot Number: SP100567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 06/14/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 06/08/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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 Age: 72 YR
• Patient Sex: Female