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

Model Number 31628

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Autoimmune Reaction (1733); Fistula (1862); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Hernia (2240)

Event Date 12/09/2013

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.

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 medical's mesh product.Allegedly, plaintiff went to hospital for abdominal pain she was having.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 records indicates that this lot of hernia mesh passed all quality inspections and performance inspections.A review of the sterility records also indicates that the product was properly sterilized with no eto cycle deviations.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

Allegedly, patient also experienced adhesions, seroma, inflammation, fistula, multiple hernias, autoimmune rejection, scar tissue and foreign body rejection.

• Brand Name: C-QUR TACSHIELD MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 6157528
• MDR Text Key: 61857774
• Report Number: 1219977-2016-00252
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2014
• Device Model Number: 31628
• Device Catalogue Number: 31628
• Device Lot Number: 10734537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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: 64 YR