MAUDE Adverse Event Report: LIFECELL STRATTICE LAPAROSCOPIC 16CM X 20CM; MESH, SURGICAL

Catalog Number	1620005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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 1st strattice on (b)(6) 2017 and a 2nd strattice on (b)(6) 2017.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.This is the same event and the same patient reported under mdr id# 1000306051-2023-00193 (abbvie complaint #(b)(4)).This mdr is being submitted for the second strattice.
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 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 13/oct/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 a recurrent incisional hernia repair and was implanted with strattice device lot sp100485; ref # (b)(4) on (b)(6) 2017.Patient experienced pain, recurrence, adhesions.The patient then underwent a "laparoscopic incisional ventral hernia repair with mesh; adhesiolysis¿ and a 2nd strattice device lot sp100529; ref #(b)(4) was implanted on (b)(6) 2017.Patient then experienced pain and recurrence and underwent laparoscopic ventral hernia repair with full thickness skin graft on (b)(6) 2019.The ppf form also indicates the patient was implanted with a non-abbvie device, "covidien/medtronic ¿ parietex composite (pco)¿ on (b)(6) 2011 and ¿covidien/medtronic ¿ parietex composite (pco)¿ implanted on (b)(6) 2011.Both devices were removed on (b)(6) 2017.As reported in the initial: limited information was reported through a legal event that a patient was implanted with 1st strattice on (b)(6) 2017 and a 2nd strattice on (b)(6) 2017.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.This is the same event and the same patient reported under mdr id# 1000306051-2023-00193 (abbvie complaint #pr (b)(4)).This mdr is being submitted for the second strattice.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.A review of the device history record for strattice lot sp100485 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.No strattice devices were returned for evaluation.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, changed, and/or corrected data: a.2., b.5., d.4., h.4., h.6.

• Brand Name: STRATTICE LAPAROSCOPIC 16CM X 20CM
• 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: 17661591
• Report Number: 1000306051-2023-00194
• Device Sequence Number: 6208015
• Product Code: FTM
• UDI-Device Identifier: 00818410012885
• UDI-Public: 00818410012885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 03/31/2019
• Device Catalogue Number: 1620005
• Device Lot Number: SP100529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female