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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Obstruction/Occlusion (2422)

Event Date 08/19/2011

Event Type  Death  

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable events may have occurred during use of atrium medicals mesh product.Plaintiff alleges that after hernia surgery and mesh implantation a pt had recurrent incisional hernia.It was also alleged that later the pt developed other issues, had other surgeries and expired.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 add'l info comes to its attention.

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.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 medical 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
• 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 ; 4038645237
• MDR Report Key: 4109388
• MDR Text Key: 21318092
• Report Number: 1219977-2014-00307
• 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: 08/28/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death