MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD; MESH, SURGICAL, POLYMERIC

Model Number 31628

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 06/19/2015

Event Type  Injury  

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.Related mdrs: 1219977-2016-00122.

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.Allegedly, after the mesh was implanted for incisional hernia repair, plaintiff developed infection.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

Manufacturer Narrative

A thorough review of the device history and sterilization records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.Based on the details of the complaint and acceptable lot qualification results atrium medical can find no fault with the product in question.

Event Description

Plaintiff also allegedly experienced non-healing wounds, dehiscence, adhesions, non-incorporated mesh and purulent drainage.

• Brand Name: C-QUR TACSHIELD
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5707165
• MDR Text Key: 46855458
• Report Number: 1219977-2016-00124
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2015
• Device Model Number: 31628
• Device Catalogue Number: 31628
• Device Lot Number: 10837225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2012
• 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: 55 YR