MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number 1620002

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

Patient Problem Hernia (2240)

Event Date 02/18/2011

Event Type  Injury  

Event Description

It was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2011.During hernia repair surgery, the surgeon implanted a strattice mesh.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2011 for a revision surgery.

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 Description

This is follow up#1 to report on 6/7/2023, pmqa received notification from legal that the lot associated with this event was found through discovery and is s10785-091.As reported in the initial: "it was reported through a legal event that a patient had hernia repair surgery on or about (b)(6) 2011.During hernia repair surgery, the surgeon implanted a strattice mesh.The records indicate the device was a strattice mesh.After surgery, patient returned to the hospital on or about (b)(6) 2011 for a revision surgery.".

Manufacturer Narrative

Internal investigation into strattice lot s10785 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 22 june 2023, all of the (b)(4) devices released to finished goods for lot s10785 have been distributed.Of the (b)(4) distributed, (b)(4) have been 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.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• 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: 16461567
• MDR Text Key: 310448473
• Report Number: 1000306051-2023-00050
• Device Sequence Number: 1
• Product Code: FTM
• 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

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: 1620002
• Device Lot Number: S10785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2010
• 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 Age: 53 YR
• Patient Sex: Female