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 Problems Adhesion(s) (1695); Hernia (2240)

Event Date 07/13/2020

Event Type  Injury  

Event 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.

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.

• 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: 15130034
• MDR Text Key: 296871897
• Report Number: 1000306051-2022-00125
• 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
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male