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

Device Problem Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had laparoscopic hernia repair approximately one year ago.Three months ago there was a query of immunodeficiency and lupus so the patient was put on steroids.Patient developed wound complications, cellulitis, abdominal pain and discharge.Surgeon took patient back into the operating room and mesh was completely intact with no incorporation into surrounding tissue.Described mesh as being like it was tofu - green in color and lumpy.Mesh was removed.Pathology on mesh and tofu-like substance came back as sterile.

• 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: 5172009
• MDR Text Key: 29198954
• Report Number: 1219977-2015-00311
• 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
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2015
• 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