MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number	1010002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 59 male patient had hernia repair surgery on or about (b)(6) 2018.During the hernia repair surgery, the surgeon implanted a strattice mesh; lot no.Sp100559.Following the initial implant of the mesh device, and due to complications concerning same, the patient was required to undergo revision surgeries, including additional mesh implantation as follows: on or about (b)(6) 2018, when the patient was implanted with:lifecell strattice mesh, lot no.Sp100622-095; (b)(6) 2018; (b)(6) 2019.When the patient was implanted with lifecell strattice mesh, lot no.: sp20009066; and (b)(6) 2020, when the patient was implanted with lifecell strattice mesh, lot no: sp20022023.This record is associated with the device implanted on august 20, 2018; lot sp100622-095.It was also reported the patient was implanted with device lot no: sp20022023 on (b)(6) 2020.However ,there is no event reported after the implantation and therefore an additional complaint record will not be opened for sp20022023.It should also be noted this in an invalid lot number.This is the same event and the same patient reported under mdr # 1000306051-2023-00100 abbvie complaint # (b)(4), and, mdr # 1000306051-2023-00101.Abbvie complaint # (b)(4).
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.Internal investigation into strattice lot sp100622, 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, of the 114 devices released to finished goods for lot sp100622, 110 have been distributed with 66 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, 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: 16871484
• Report Number: 1000306051-2023-00102
• Device Sequence Number: 20282696
• Product Code: FTM
• UDI-Device Identifier: 00818410010096
• UDI-Public: 00818410010096
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 05/04/2023

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: 03/31/2020
• Device Catalogue Number: 1010002
• Device Lot Number: SP100622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2018
• 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: 59 YR
• Patient Sex: Male