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	Adhesion(s) (1695); Hernia (2240); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/06/2024
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 and (b)(6) 2024.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 patient reported under patient identifier (b)(6).This emdr is being submitted for 1st strattice.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp200306 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.
Event or Problem Description
This is follow up#1 to report on 21/apr/2025, pmqa received notification from legal that the plaintiff profile form (ppf).As per the ppf form, the patient underwent a repair of incarcerated incisional hernia and patient was implanted with the strattice device lot# sp200306-054, ref.#1016005 on (b)(6) 2022.On (b)(6) 2024, patient underwent removal of old mesh and repair of complex incisional hernia with two non-abbvie devices, symbotex meshes with model #sym2520 and #sym12.On (b)(6) 2024, drainage intra-abdominal abscess, removal of mesh, repair recurrent incisional hernia with 2nd strattice biologic mesh with unknown lot number and catalog number 1016002p, wound vac placement.On (b)(6) 2024, secondary wound closure.The form lists the condition that was treated: (b)(6) 2022, repair of incarcerated incisional hernia (strattice).(b)(6) 2024, removal of old mesh; lysis of adhesions, repair of complex incisional hernia with two symbotex meshes.(b)(6) 2024, exploratory laparotomy, drainage of intra-abdominal abscess, removal of mesh, repair recurrent incisional hernia with strattice biologic mesh, wound vac placement.(b)(6) 2024, open wound of the abdomen; secondary wound closure (general anesthesia).(b)(6) 2024, chronic open wound of abdomen wall; wound drainage; wound closure; redundant skin half dollar size ulceration of the abdominal wall; silver nitrate applied; wound vac.Approx.(b)(6) 2024, wellness check; wound care; wound vac management/monitoring; medication management.Approx.2004-present, hernia symptoms, recurring hernias, failed mesh implants, hernia surgeries, follow-up.2022-present, primary care; hospital follow-up; abdominal pain; wound checks.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2022 and (b)(6) 2024.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 patient reported under patient identifier (b)(6).This emdr is being submitted for 1st strattice.

• 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: 21267433
• Report Number: 1000306051-2025-00008
• Device Sequence Number: 14368508
• Product Code: FTM
• UDI-Device Identifier: 00818410012823
• UDI-Public: (01)00818410012823(10)SP200306(11)210617(17)230430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/24/2025

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: 04/30/2023
• Device Catalogue Number: 1016005
• Device Lot Number: SP200306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2021
• 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: Male