MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC

Model Number 31540

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)

Event Date 11/14/2014

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical mesh product.It was alleged that the mesh was explanted because of pain and recurrent hernia.Since this is a potential legal matter, the case has been turned over to legal counsel and further info obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplemental this report as appropriate if additional info comes to its attention.

Manufacturer Narrative

A review of manufacturing and sterilization records was performed and there was not any problems noted that would impact this report.A review of the medical record provided was completed.The records indicate that the pt had prior abdominal surgery and developed multiple ventral hernias at the incision.During repair of the hernias with mesh it was noted that there were many incarcerated omental adhesions.Culture results revealed no infection.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4575237
• MDR Text Key: 18633740
• Report Number: 1219977-2015-00055
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 31540
• Device Catalogue Number: 31540
• Device Lot Number: 106595909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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: GORE STAY SUTURES
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR