MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number 2025002

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

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 08/25/2014

Event Type  Injury  

Manufacturer Narrative

This is a known potential adverse event addressed in the product labeling.

Event Description

Patient underwent primary ventral incisional hernia repair surgery and stattice mesh implanted.Patient returned to the hospital 3 years later and was diagnosed with partial small-bowel obstruction and a recurrent ventral incisional hernia with incarceration.Mesh removed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11614906
• MDR Text Key: 243806637
• Report Number: 1000306051-2021-00024
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010157
• UDI-Public: 00818410010157
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2025002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR