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

Model Number 31542

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240)

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, following the implant of mesh plaintiff experienced failure of mesh to properly incorporate, chronic pain, foreign body response, infection, scarification, excessive and chronic inflammation, adhesions to internal organs, abscess, seroma formation, panniculitis, inability to remove mesh in its entirety and other complications.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

Allegedly, patient also experienced recurrence of hernia, chronic non-healing wound, and wound drainage.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• 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: 6785015
• MDR Text Key: 82419797
• Report Number: 3011175548-2017-00081
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: 31542
• Device Catalogue Number: 31542
• Device Lot Number: 10846776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2012
• 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 Weight: 126