MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM; MESH, SURGICAL

Catalog Number	2540002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with 1st strattice and 2nd strattice firm on (b)(6) 2023.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.This is the same event and the same patient reported under patient identifier (b)(6) (emdr- (b)(4) ).This emdr is being submitted for the 2nd strattice firm.
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, 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.
Event or Problem Description
This is follow up#1 to report on (b)(6) 2025, pmqa received notification from legal that the plaintiff profile form was received associated with this event.This record captures the first listed strattice device lot sp200471-041.As per the ppf form, the patient underwent an ¿incisional hernia¿ surgery and was implanted with strattice devices lots ¿sp200471-041,¿ ¿sp200503-106,¿ and ¿sp200531-007¿ on (b)(6) 2023.The patient underwent a ¿repair of recurrent defect due to non-adherence of prior mesh, removal of old stretched mesh¿ on (b)(6) 2024 and replaced with a non-abbvie device, ¿bard phasix st - ref: (b)(4).The form lists the conditions that were treated were ¿long infection, abscess, extensive hospitalization, seroma, pain¿ between (b)(6) 2023 and (b)(6) 2025.The patient was then treated for ¿mrsa infection¿ between (b)(6) 2023 and (b)(6) 2023.The patient received treatment for ¿infection, pain, fever, abdominal wall fluid collection¿ between (b)(6) 2023 and (b)(6) 2023.The patient received ¿pain management¿ from 2024-2025.The ppf form also indicates that the patient was implanted with a non-abbvie device, ¿bard phasix st - ref: (b)(4),¿ on (b)(6) 2024.The form does not indicate whether this device was removed or revised.The plaintiff also sought treatment for ¿edema, numbness, pain in left leg; informed it was nerve damage¿ in (b)(6) 2025.The plaintiff also received evaluation of ¿swelling, numbness, pain in left leg; informed it was not a vascula issue¿ in (b)(6) 2025.The plaintiff had a ¿nerve conduction test indicates signs of nerve damage involved in areas of scar tissue and fibrosis around the surgical site¿ between (b)(6) 2025 and (b)(6) 2025.The plaintiff was also seen for ¿pain, referrals¿ from 2023 to 2025.As reported in the initial: limited information was reported through a legal event that a patient was implanted with 1st strattice and 2nd strattice firm on (b)(6) 2023.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.This emdr is being submitted for the 2nd strattice firm.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp200503 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.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.Additional and/or corrected data: a2, b2, b3, b5, b7, d4, d6b, h4, h6.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: terry ingram ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 22903559
• Report Number: 1000306051-2025-00080
• Device Sequence Number: 7911357
• Product Code: FTM
• UDI-Device Identifier: 00818410010416
• UDI-Public: (01)00818410010416(10)SP200503(11)230306(17)250131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 01/31/2025
• Device Catalogue Number: 2540002
• Device Lot Number: SP200503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female