MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number	2025002
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	12/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was reported through a legal event that a patient was implanted with strattice firm on (b)(6) 2020.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
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
On 11/aug/2025, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent an ¿incisional hernia¿ surgery and was implanted with a strattice device on (b)(6) 2020.The patient underwent a ¿repair of recurrent incisional hernia with mesh¿ on (b)(6) 2022.As per the ppf form, the patient claims the implantation and failure of the mesh caused the following injuries: ¿physical injury, loss of enjoyment of life, and economic and non-economic losses as a result of [their] strattice implant.[the plaintiff] is dependent on others to help with tasks [they have] difficulty completing [themselves.] these injuries contribute to [the plaintiff¿s] anxiety and depression.¿ the form lists the conditions that were treated were ¿extensive lysis of adhesions, small bowel resections x3, partial transverse colectomy, gastrojejunostomy billroth ii, excision of abdominal wall scar and infected mesh, abdominal reconstruction with component separation creating skin flaps, care of an incisional hernia with stratus mesh; enterocutaneous fistula¿ between (b)(6) 2020.The patient was then treated for ¿nausea, vomiting, abdominal pain, and distention¿ between (b)(6) 2020.The patient underwent ¿repair of recurrent incisional hernia with mesh (ventralex mesh)¿ on or about (b)(6) 2022.The patient was treated for ¿diasteses at incision site¿ on or about (b)(6) 2022.The patient also received treatment for ¿abdominal abscess/infection¿ between (b)(6) 2024.The patient received ongoing treatment for ¿anxiety, depression, hernia related issues¿ between 2018-present.The ppf form also indicates that the patient was implanted with a non-abbvie device, ¿sepramesh, lot number unknown¿ on (b)(6) 2010.The device was revised on (b)(6) 2019 due to ¿incisional hernia repair with mesh.¿ the patient was implanted with a second non-abbvie device, ¿ventralex implant, lot number unknown¿ on (b)(6) 2019.The device was revised on (b)(6) 2020 due to ¿ct guided aspiration of abscess.¿ the device was further revised on (b)(6) 2020 due to ¿extensive lysis of adhesions, small bowel resections x3, partial transverse colectomy, gastrojejunostomy billroth ii, excision of abdominal wall scar and infected mesh, abdominal reconstruction with component separation creating skin flaps, care of an incisional hernia with strattice mesh.¿ the patient was implanted with a third non-abbvie device, ¿ventralex implant, lot number unknown¿ on (b)(6) 2022.The form does not indicate whether this device was removed or revised.The form indicates the patient has a history of ¿broken back, 4 back surgeries.¿.
Additional Manufacturer Narrative
Additional and/or corrected data: a2, b3, b5, b7, d1, d4, h4, h6.A review of the device history record for strattice lot sp200154 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, 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: 21620933
• Report Number: 1000306051-2025-00038
• Device Sequence Number: 8510200
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: (01)00818410010157(10)SP200154(11)210105(17)210831
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 08/31/2021
• Device Catalogue Number: 2025002
• Device Lot Number: SP200154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2021
• 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: 64 YR
• Patient Sex: Male