MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE; MESH, SURGICAL

Catalog Number	0608001
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	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 52 year old male patient had hernia repair surgery on or about (b)(6) 2016.During the hernia repair surgery the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital, on or about (b)(6) 2020, for a revision surgery.
Additional Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, and without relevant patient factors, a relationship between the event and strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to post market quality assurance for further evaluation.To date, no additional information has been received.No further actions are required, a nonconformance was not confirmed.
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 sp100275 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.
Event or Problem Description
This is follow up#1 to report on 19/jan/2024, 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 ¿paraoesophageal hernia repair¿ surgery and was implanted with strattice device lot sp100275-202 on (b)(6) 2016.The patient underwent an ¿laparoscopic redo hiatal hernia repair with nissen fundoplication¿ on (b)(6) 2020.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿physical injury (adhesions to mesh), pain and suffering, loss of enjoyment of life, disfigurement, and economic and non-economic losses.¿ the form lists the conditions that were treated were ¿lysis of adhesions and removal of old mesh, repair of recurrent defect¿ with approximate dates of treatment around (b)(6) 2020.Patient was ¿prescribed gi compound and botox shots in neck¿ with approximate dates of treatment between 2021 to present.As reported in the initial: it was reported through a legal event that a 52 year old male patient had hernia repair surgery on or about (b)(6) 2016.During the hernia repair surgery the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital, on or about (b)(6) 2020, for a revision surgery.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE
• 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: 15130034
• Report Number: 1000306051-2022-00125
• Device Sequence Number: 12203998
• Product Code: FTM
• UDI-Device Identifier: 00818410010003
• UDI-Public: 00818410010003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/16/2024

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: 06/30/2017
• Device Catalogue Number: 0608001
• Device Lot Number: SP100275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male