MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number	1016002
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Abscess (1690); Cellulitis (1768); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/16/2019
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 on (b)(6)2018.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.
Additional Manufacturer Narrative
A review of the device history record for strattice lot sp100581 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, b7, d3, d4, h4, h6.
Event or Problem Description
This is follow up#1 to report on 14/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 two strattice devices on (b)(6) 2018.The patient underwent an ¿incision & drainage of abdominal wall abscess, debridement¿ on (b)(6) 2019.The patient underwent an ¿abscess drainage/incision & drainage¿ on (b)(6) 2021.The patient underwent an ¿incision & drainage¿ on (b)(6) 2021.The patient underwent a ¿non-healing suture abscess, suture removal, abscess cavity debrided¿ on (b)(6) 2021.The form lists the conditions that were treated were ¿open incisional hernia repair (2-layer sandwich mesh repair with strattice and a primary fascia closure); abscess cavity debrided¿ between (b)(6) 2018.The patient was then treated for ¿incision & drainage of abdominal wall abscess; debridement¿ on (b)(6) 2019.The patient received treatment for ¿abdominal wall pain; abdominal wall abscess; abscess drainage/incision & drainage¿ on or about (b)(6) 2021.The patient received ¿incision & drainage; chronic abdominal wound infection; suture abscess (suture cut); intubation¿ on or about (b)(6) 2021.The patient also received treatment for ¿non-healing suture abscess; suture removal; abscess cavity debrided; scar tissue removal; wound vac placed¿ on or about (b)(6) 2021.The patient received ongoing treatment for ¿wound care¿ between approximately 2018-2022.The patient was treated for ¿abdominal pain; wound check; cellulitis of abdominal wall¿ on or about (b)(6) 2021.The patient was seen for ¿primary care; hernia symptoms; abdominal wall pain; abdominal wall abscess¿ between approximately 2017 to present.The patient received treatment for ¿abdominal wall pain; abdominal wall abscess; abscess drainage/ i & d; chronic abdominal wound infection¿ between (b)(6) 2021.The patient was seen for ¿chronic abdominal wound infection; nonhealing suture abscess; post-op follow-ups¿ between 2021 and 2022.The ppf form also indicates that the patient was implanted with two non-abbvie devices, ¿ventralex mesh,¿ on (b)(6) 2016.The devices were revised on (b)(6) 2016 due to ¿excision of old mesh and open ventral hernia repair with suture.¿ the devices were subsequently revised on (b)(6) 2018 due to ¿open incisional hernia repair (2-layer sandwich mesh repair with strattice and a primary fascia closure).¿ the devices were also revised on (b)(6) 2019 due to ¿incision & drainage of abdominal wall abscess, debridement.¿ the devices were revised on (b)(6) 2021 due to ¿abscess drainage/incision & drainage.¿ the devices were also revised on (b)(6) 2021 due to ¿incision & drainage.¿ the devices were also revised on (b)(6) 2021 due to ¿suture removal, abscess cavity debrided, scar tissue removal, wound vac placement.¿ as reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2018.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, 10 X 16, 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: 21612584
• Report Number: 1000306051-2025-00037
• Device Sequence Number: 7565047
• Product Code: FTM
• UDI-Device Identifier: 00818410010119
• UDI-Public: (01)00818410010119(10)SP100581(11)171112(17)191031
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 10/31/2019
• Device Catalogue Number: 1016002
• Device Lot Number: SP100581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2017
• 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: 56 YR
• Patient Sex: Male