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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation into this event has been completed.

Event Description

Received report of an event of fistula following patient being implanted with mesh.

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.There is no indication that this event is due to a device failure.Clinical evaluation: fistulas are a known complication of incisional hernia repairs using prostheses.Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, smoking, diabetes mellitus, elder age and poor nutritional status.Fistulas are a late complication of repairs with mesh particularly if the mesh is in direct contact with the intestine and may be caused by chronic infection.Drainage creates a tract from one space to another, this is called a fistula.The instructions for use state complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and fistula formation, mechanical disruption of the tissue and/or mesh material when placed in direct contact with the viscera and organs.

Manufacturer Narrative

Corrected report date.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 6142172
• MDR Text Key: 61351871
• Report Number: 1219977-2016-00244
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2011
• 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