MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

Model Number 31533

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Hernia (2240)

Event Date 06/20/2013

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 medicals mesh product.Patient operative report states ventral incisional hernia with infected prosthetic mesh and colocutaneous fistula at time of explant.Since this is a potential 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 review of the device history records and sterilization records was reviewed and no problems were noted that would impact this event.A review of complaints was conducted and there have been no similar reports due to a device failure.A review of the complaints also confirmed that we have not received any other reports on this device lot number.This report is based upon allegations made in a lawsuit in which atrium medical is named defendant.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3708954
• MDR Text Key: 18624525
• Report Number: 1219977-2014-00100
• 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: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 31533
• Device Catalogue Number: 31533
• Device Lot Number: 10852865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: QUILTING SUTURES; 2-0 VICRYL; XENMATRIX 15 X 20 CM SURGICAL GRAFT: LOT HUXD2260; ON-Q PAIN PUMP CATHETER; SKIN STAPLES; TWO 19 FRENCH BLAKE DRAINS; #2 PDS
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR