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)
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) 2016.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
This legal event is being reported out of an abundance of caution as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, 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
This is follow up#1 to report on 01/aug/2023, 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 umbilical hernia repair and was implanted with strattice device lot (b)(6), 0610008 on (b)(6) 2016.The patient was treated for ¿pain¿, ¿recurrence" and ¿adhesions¿ and underwent a " recurrent ventral hernia repair with mesh, exploratory laparotomy, and lysis of adhesions" on (b)(6) 2021 and was implanted with a non-abbvie device, " bard/davol ¿ ventralex¿.No "revision or removal" was reported for the non-abbvie device.No other information was reported.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2016.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 sp100185 has been completed.No deviations or non-conformances noted.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: 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: 17198995
• Report Number: 1000306051-2023-00139
• Device Sequence Number: 12447910
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 09/30/2016
• Device Catalogue Number: 0610008
• Device Lot Number: SP100185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male