MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, FIRM; MESH, SURGICAL

Catalog Number	2030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2021
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 firm on (b)(6) 2019.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 sp100555 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 22/apr/2025, pmqa received notification from legal that the plaintiff profile form (ppf).As per the ppf form, the patient underwent a repair of recurrent ventral incisional herniorrhaphy with an inlay biologic mesh, extensive lysis of adhesions, removal of intra-abdominal mesh with a bilateral component separation procedure, bilateral components separation muscle flap hernia closure, repair of ventral hernia, placement of mesh in hernia, use of biologic mesh for reinforcement of hernia repair with strattice device lot# sp100555059, ref.#2030002 on (b)(6) 2019.On (b)(6) 2021, repair incisional hernia with mesh (non abbvie device, progrip lot #svd0560x).The form lists the condition that was treated: (b)(6) 2019, recurrent ventral incisional hemiorrhaphy with an inlay biologic mesh, extensive lysis of adhesions, removal of intra- abdominal mesh with a bilateral component separation procedure bilateral components separation muscle flap hernia closure, repair of ventral hernia, placement of mesh in hernia, use of biologic mesh for reinforcement of hernia repair.(b)(6) 2019, worsening abdominal pain; ct: status post mesh repair along the anterior abdominal wall with induration of the subcutaneous fat of the anterior abdominal wall and rectus muscles.(b)(6) 2021, worsening abdominal pain, nausea; diagnostic testing; ct ab/pel: right ventral hernia with small bowel contents.(b)(6) 2021, repair incisional hernia with a non-abbvie mesh (progrip lot #svd0560x).(b)(6) 2021, abdominal pain; ct ab/pel: right lower quadrant, subcutaneous encapsulated collection identified could represent a seroma.Approx.2015-2021/2022, primary care; depression and anxiety; abdominal pain; hernia symptoms; post-op.2021/2022-2024, primary care, abdominal pain, depression and anxiety.(b)(6) 2018-2019, abdominal pain; hernia symptoms, hernia repair, post-op.(b)(6) 2018-2019, abdominal pain; reevaluation of ventral incisional hernia; diagnostic testing; hernia symptoms, hernia repair; post-op.(b)(6) 2021-2022, hernia symptoms, recurrent hernia; prep for hernia repair; ct scans/imaging; hernia repair; hernia follow-up.(b)(6) 2025, abdominal pain.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2019.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 RECONSTRUCTIVE TISSUE MATRIX, 20 X 30, 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: 21267332
• Report Number: 1000306051-2025-00007
• Device Sequence Number: 12874371
• Product Code: FTM
• UDI-Device Identifier: 00818410010393
• UDI-Public: (01)00818410010393(10)SP100555(11)190107(17)190731
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 07/03/2019
• Device Catalogue Number: 2030002
• Device Lot Number: SP100555
• 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: 04/22/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2019
• 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