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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient reported that she had a mesh implanted in 2013, for a very large "swiss cheese" hernia.The mesh had to be removed in (b)(6) 2015 due to complications.

Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided.Clinical evaluation: hernias emerge through preformed or acquired defects or weak areas of the abdominal wall unprotected by muscle or aponeurosis.There are dozens of types and subtypes of abdominal wall hernias, ranging from the simple groin hernia to the complex and rare.A "swiss cheese hernia" occurs when multiple hernia sites occur in a localized area of the abdominal wall.It was reported that the patient required explant of the mesh due to unspecified complications follow the repair of a very large complex and rare hernia.Complications may occur due to a technical error, inadequate suture fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions, fistula formation and pain.The compromised patient undergoing a second surgery for explant has increased risks.The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines).

• 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: 5201388
• MDR Text Key: 30394757
• Report Number: 1219977-2015-00321
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• 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: 11/03/2015
• 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
• Patient Age: 45 YR
• Patient Weight: 81