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

Model Number	31106
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
Received a report that patient needed mesh removed due to infection.Doctor reported that the patient had infection at two port entries and behind the muscle in front of mesh.
Additional Manufacturer Narrative
A review of lot history and sterilization records was performed.The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy, suture retention strength and ball burst strength.All raw materials met all incoming testing and inspections.Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release.Clinical evaluation: a port site infection may be the result of contamination at the time of insertion, the location of the entry or a dressing may lose its integrity and expose the site to contaminants.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.Other risks for ssis include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.Most infections can be treated successfully with antibiotic medications, although, sometimes additional surgery or procedures may be required.The instructions for use precaution against handling of the mesh without clean sterile gloves and instruments.It states in adverse reactions, "complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs.

• Brand Name: C-QUR MOSAIC
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP; merrimack NH 03054
• MDR Report Key: 5574515
• Report Number: 3011175548-2016-00001
• Device Sequence Number: 19014205
• Product Code: FTL
• UDI-Device Identifier: 00650862311068
• UDI-Public: 00650862311068
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151386
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2016

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: 11/30/2018
• Device Model Number: 31106
• Device Catalogue Number: 31106
• Device Lot Number: 403700
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 04/26/2016
• 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
• Patient Age: 52 YR