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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/18/2014
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) 2014.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 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.
Additional Manufacturer Narrative
A review of the device history record for strattice lot s11282-140 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.These are known potential adverse events addressed in the product labeling.A relationship between the strattice and these 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
Limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2014.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.On 13/nov/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 ventral incisional hernia¿ repair and was implanted with strattice device on (b)(6)2014.The patient underwent a "diagnostic laparoscopy with laparoscopic lysis of adhesions, excision of intraabdominal foreign material and laparoscopic ventral hernia repair¿ on (b)(6)2014.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿adhesions, pain, recurrence and intervention surgery¿.The form lists the conditions that were treated were ¿adhesions, pain, recurrence and intervention surgery¿ with approximate dates of treatment as (b)(6)2014.The ppf form also indicates the patient was implanted with a non-abbvie device, "covidien/medtronic parietex¿ during the (b)(6) 2014 procedure.In addition, the form indicates patient sought treatment for ¿prolapsed bladder pessary¿ on or around (b)(6)2021 and for ¿infections from pessary¿ on or around (b)(6)2021.

• 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: 17773970
• Report Number: 1000306051-2023-00219
• Device Sequence Number: 6252979
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 04/30/2015
• Device Catalogue Number: 1620005
• Device Lot Number: S11282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• 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: 65 YR
• Patient Sex: Female