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

Model Number	31540
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon the conclusion of the investigation into this event.
Event or Problem Description
Patient with ventral hernia in which a mesh did not integrate.The patient developed wound infection eight weeks after surgery and the mesh was removed.Cultures showed enterobacteriaceae staphylococcus.Antibiotics were given.
Additional Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted.All in-process specifications and release criteria were met, including testing for suture retention and ball burst conducted on the mesh at incoming.Fournier transform infrared spectroscopy testing and coating density of the cured omega-3 fatty acids coated panels and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met.Clinical evaluation: a mesh may not integrate due to, but not limited to infection, incorrectly sized mesh or inadequate fixation.This event could require the patient to undergo a second surgery to correct the defect in order to prevent further complication.C-qur mesh products are provided sterile.The handling of all mesh should be with sterile gloves and/or instruments.Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.Enterobacteriaceae is a bacterial infection that makes up as many as half of the hospital acquired infections in the united states.Other risks for surgical site infections (ssi) include smoking, elderly and/or overweight patients, those with weakened immune systems and diabetes.Most ssis can be treated successfully with antibiotic medications.Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue.The instructions for use state adequate mesh fixation is required to minimize post-operative complications and recurrence and complications may occur with the use of any surgical mesh include, but are not limited to pain, seroma, mechanical disruption of the tissue and /or mesh and adhesions when placed in direct contact with the viscera and other organs.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6148626
• Report Number: 3011175548-2016-00013
• Device Sequence Number: 10986249
• Product Code: FTL
• UDI-Device Identifier: 00650862315400
• UDI-Public: 00650862315400
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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
• Operator of Device: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 31540
• Device Catalogue Number: 31540
• Device Lot Number: P15332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention