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

Model Number 31533

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Microcyst(s) (1960); Seroma (2069)

Event Date 02/28/2012

Event Type  Injury  

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 med mesh product.Plaintiff alleged that he had a mesh implanted and suffered an adverse reaction including but not limited to: inflammatory response, granulomatous formation, abcess and/or seroma onset, infectious propagation, and/or lack of proper ingrowth, and as a result the mesh was surgically removed.Since this is a 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 supplement this report as appropriate if additional info comes to its attention.

Manufacturer Narrative

Investigation: review of mfg and sterilization records found no issues during manufacture or sterilization.This report is based upon allegations made in a lawsuit in which atrium medical is named defendant.This report shall not be considered as an admission by atrium med that the product described in the lawsuit and described herein are or were defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4216385
• MDR Text Key: 17991643
• Report Number: 1219977-2014-00364
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 31533
• Device Catalogue Number: 31533
• Device Lot Number: 10749462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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: 55 YR