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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2013

Event Type  Injury  

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided and there is no contact information for the complainant.Clinical evaluation.Possible complications that should be considered prior to the use of any surgical mesh include pain and inflammation to name a few.Complications may be caused by stress on the mesh due to activity, body habitus or incorrect mesh fixation.The fixation technique, method and products used are left solely to the discretion of the surgeon to optimize clinical outcomes.Important aspects of user experience include the necessity of having operative planning with full identification of the extent of the hernia, adept skills in the application of sutures/tacks, and reconstruction skills assuring closure of the wound in layers and coverage of the implanted mesh with minimal space for serous collections and no direct pathway to the mesh from the skin.

Event Description

Received a report that a patient was implanted with mesh for repair of inguinal hernia.Approximately one year later patient's body rejected mesh requiring removal of mesh.

Manufacturer Narrative

This follow up report is for the inclusion of report mw5058864 attachment.

• 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: 5393805
• MDR Text Key: 36910510
• Report Number: 1219977-2016-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2016
• 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