MAUDE Adverse Event Report: LIFECELL 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET; MESH, SURGICAL

Catalog Number	0610008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.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) 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
Additional and/or corrected data: a2, b3, b5, d1, d4, h4, h6.A review of the device history record for strattice lot sp100601 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.A relationship between the strattice and this event could not be conclusively 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 15/feb/2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event on (b)(6) 2024.As per the ppf form, the patient underwent a ¿peristomal¿ hernia surgery and was implanted with strattice device on (b)(6) 2018.The patient underwent an ¿injury (adhesions, recurrence) + exploratory laparotomy, extensive lysis of adhesions and enterolysis, repair of parastomal hernia, incisional hernia repair, recurrent¿ on (b)(6) 2022.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿adhesions, pain, hernia recurrence.¿ the form lists the conditions that were treated were ¿hernia¿ with approximate dates of treatment between 2021 and 2023.The patient underwent treatment for ¿hernia¿ with approximate dates of treatment between 2017 and 2019.

• Brand Name: 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 18155408
• Report Number: 1000306051-2023-00272
• Device Sequence Number: 6588567
• Product Code: FTM
• UDI-Device Identifier: 00818410010041
• UDI-Public: 00818410010041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 12/31/2019
• Device Catalogue Number: 0610008
• Device Lot Number: SP100601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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