MAUDE Adverse Event Report: LIFECELL STRATTICE LAPAROSCOPIC 10CM X 16CM; MESH, SURGICAL

Catalog Number	1016005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Impaired Healing (2378); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/21/2023
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) 2014.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.The patient noted to be deceased, deemed not device related.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 has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch 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.The event is a known potential adverse event addressed in the product labeling.Additional, corrected, and/or changed data: a2, b3, b5, d4, d6b, h4, h6.
Event or Problem Description
This is follow up#1 to report on 13/jun/2025, pmqa received notification from legal that the plaintiff profile form (ppf) was received.As per the ppf form, the patient underwent a ventral incisional hernia surgery and was implanted with a strattice device lot # sp100007, reference #1525002 on (b)(6) 2014.On (b)(6) 2023 , patient underwent excision of the infected mesh from the hernia and resection of part of the small bowel.Patient experienced mesh erosion through, dense scar tissue around area and fistula formed between the small bowel and another pat of the gastrointestinal tract with open wound on the abdomen that would drain and needing to be patched up.The form lists the condition that was treated: (b)(6) 2003, placement of prolene soft polypropylene mesh.On (b)(6) 2014, partial removal of prolene soft polypropylene mesh and placement of strattice mesh.On (b)(6) 2023, performed the removal of the strattice mesh.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2014.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.The patient noted to be deceased, deemed not device related.No information was provided on the indication for the initial surgery or the reason for the removal or revision.

• Brand Name: STRATTICE LAPAROSCOPIC 10CM X 16CM
• 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: 21960580
• Report Number: 1000306051-2025-00048
• Device Sequence Number: 20620860
• Product Code: FTM
• UDI-Device Identifier: 00818410012823
• UDI-Public: (01)00818410012823(10)SP100007(11)130730(17)150630
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 06/24/2025

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: 06/30/2015
• Device Catalogue Number: 1016005
• Device Lot Number: SP100007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2013
• 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: 69 YR
• Patient Sex: Male