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

Model Number 31528

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

Received report of a patient developing a rash that would not clear up three months after implanting mesh.

Manufacturer Narrative

We are unable to fully investigate this event as no lot number or sample was provided.Complainant has not answered requests for additional information.Clinical evaluation: rash is not a specific diagnosis.Instead it means skin inflammation and discoloration that changes the way the skin looks.It is a general term that describes an inflammation of the skin.A rash can have many causes and occurs in many forms.It usually involves an itchy rash on swollen, reddened skin.A rash is a common condition that's not contagious and usually isn't life-threatening.In a certain percentage of people with a skin reaction the cause may not be readily apparent or characterized.In these cases, the origin of the condition is said to be idiopathic.The instructions for use state in adverse reactions complications that may occur with the use of any surgical mesh include inflammation and infection.A skin reaction may be due to a foreign body response, or an introduction of bacteria or even environmental factors.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5219060
• MDR Text Key: 30983215
• Report Number: 1219977-2015-00326
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31528
• Device Catalogue Number: 31528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• 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): Required Intervention