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

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Received a scientific article, titled "outcomes following 385 consecutive implantations of omega-3 fatty acid coated mesh"; per the article, "intraperitoneal placement of mesh requires the presence of an adhesion barrier to minimize adhesions, pain, and infectious complications.Barrier options include monolayer and hybrid mesh products.A single surgeon's 5-year experience with mesh utilizing a biologic coating of omega-3 fatty acid is presented." per the article, one patient presented with skin reactions (idiopathic).

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, sample or additional information were provided.According to the paper, the complication profile of o3fa coated mesh is comparable to that reported for other meshes.O3fa use is associated with reasonable outcomes, excellent patient tolerance, and effective hernia repair.It is now the prosthetic of choice for intraperitoneal placement at our institution.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4076445
• MDR Text Key: 4832952
• Report Number: 1219977-2014-00251
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• 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