MAUDE Adverse Event Report: LIFECELL STRATTICE PERFORATED 20 X 30; MESH, SURGICAL

Catalog Number	2030002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
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
Limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2022.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.
Additional Manufacturer Narrative
A review of the device history record for strattice lot: sp200416 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.Additional and/or corrected data: a2, b3, b5, d4, d6b, h4, h6.
Event or Problem Description
This is follow up#1 to report on 9/jul/2025, pmqa received notification from legal that the plaintiff profile form (ppf) has been received.As per the ppf form, the patient underwent a repair of recurrent ventral hernia repair with strattice device lot number: sp200416-191 and ref.#: (b)(4) on (b)(6) 2022.On (b)(6) 2023, patient underwent an exploratory surgery with removal of previously placed mesh.As per the ppf form, the patient claimed the failure of the mesh caused chronic pain, an abscess and an infection which required an additional surgical procedure where the strattice hernia mesh was removed.The form lists the condition that was treated: 2023 - abscess, infection, severe pain and all other conditions.The ppf form also indicates that the patient was implanted with a non-abbvie device, covidien on (b)(6) 2012.On (b)(6) 2022, covidien was removed due to adhesions, migration, and hernia recurrence.Patient was implanted with a non-abbvie device, ethicon on (b)(6) 2022.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2022.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.

• Brand Name: STRATTICE PERFORATED 20 X 30
• 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: 22014326
• Report Number: 1000306051-2025-00053
• Device Sequence Number: 20804313
• Product Code: FTM
• UDI-Device Identifier: 00818410012496
• UDI-Public: (01)00818410012496(10)SP200416(11)220711(17)240531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 05/31/2024
• Device Catalogue Number: 2030002P
• Device Lot Number: SP200416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2022
• 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: 63 YR
• Patient Sex: Female