MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 40, FIRM; MESH, SURGICAL

Catalog Number 2040002

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

Patient Problem Hernia (2240)

Event Date 05/21/2015

Event Type  Injury  

Event Description

It was reported through a legal event that a (b)(6) female patient underwent hernia repair surgery on or about (b)(6) 2011.During the hernia repair surgery, the surgeon implanted two strattice meshes.The records indicate these were a strattice firm 16 x 20 and strattice firm 6 x 16 mesh.After surgery, the patient had several revision surgeries including: (b)(6) 2012, during which a strattice firm 10 x 16 mesh was implanted, (b)(6) 2014, revision surgery during which a strattice firm 16 x 20 mesh was implanted and (b)(6) 2015, surgery during which a strattice firm 20 x 40 mesh was implanted.This record is associated with the fifth strattice firm 20 x 40 mesh implanted on (b)(6) 2015.Record 4 of 5.

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 of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.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, 20 X 40, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14147978
• MDR Text Key: 290453381
• Report Number: 1000306051-2022-00055
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010409
• UDI-Public: 00818410010409
• 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
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2040002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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