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

Catalog Number 0608001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 06/16/2021

Event Type  Injury  

Event Description

It was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2021, for a mesh revision operation.

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.

Manufacturer Narrative

Internal investigation into strattice lot sp100549 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 15 march 2023, of the (b)(4)devices released to finished goods for lot sp100549, 156 have been distributed with 62 reported as implanted.Based on our internal investigation with no remarkable findings, and 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.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.

Event Description

This is follow up#1 to report the results from the internal investigation and the conclusion.The aware date is based on when the batch record review was completed.As reported in the initial: it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6), 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6), 2021, for a mesh revision operation.

Event Description

This is follow up#2 to report that on (b)(6) 2023, pmqa received notification from legal that although a lot was provided in the original summons, the valid lot associated with this event was found through discovery and is sp100548-321.No other information was reported.As reported in initial: it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2018.During hernia repair surgery, the surgeon implanted a strattice mesh, lot number: sp100549.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2021, for a mesh revision operation.

Manufacturer Narrative

A review of the device history record for strattice lot sp100548 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.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: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 6CM X 8CM, PLIABLE
• Type of Device: 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: 16512028
• MDR Text Key: 310962323
• Report Number: 1000306051-2023-00053
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010003
• UDI-Public: 00818410010003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 0608001
• Device Lot Number: SP100548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION REPORTED
• Patient Outcome(s): Required Intervention
• Patient Sex: Female