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

Model Number	31107
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Hospital reported they had tightened transfacial sutures and ran the arm of the tacker across the mesh to reach the other side, coating flaked off where mesh was pulled tight.Also flaked at site of tied sutures.
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 (course and wale) and ball burst conducted on the mesh at incoming.Fourier-transform infrared spectroscopy testing, in-process visual inspection of the cured coated mesh/panels, coating density of the cured 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: c-qur¿ mosaic mesh has a coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bio-absorbable oil coating).It has a coating that is absorbable by the body and if in the event it does flake or come off during a procedure it would cause no harm to the patient, the mesh would then become the equivalent of bare mesh.A physician may determine a product is not suitable for an intended procedure at any time and for any reason he deems significant enough to compromise patient outcomes.In the event the physician has a change of plan during a procedure it would result in a delay in treatment.The instructions for use state under adverse reaction, that complications may occur with the use of any surgical mesh include, but are not limited to, 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.; 40 continental blvd.; merrimack NH 03054
• MDR Report Key: 6175291
• Report Number: 3011175548-2016-00014
• Device Sequence Number: 255472
• Product Code: FTL
• UDI-Device Identifier: 00650862311075
• UDI-Public: 00650862311075
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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: 04/05/2019
• Device Model Number: 31107
• Device Catalogue Number: 31107
• Device Lot Number: 405521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECURESTRAP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR