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

Model Number 31591

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hernia (2240)

Event Date 10/21/2014

Event Type  Injury  

Event Description

Repair of recurrent large ventral hernia.The hernia re-herniated through the initial mesh.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the eval is completed.

• 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: 4249799
• MDR Text Key: 16560233
• Report Number: 1219977-2014-00372
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: 31591
• Device Catalogue Number: 31591
• Device Lot Number: 10803818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: ABSORBABLE TACKS (PROTACKERS)
• Patient Outcome(s): Required Intervention