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

Model Number	31106
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
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 that they have a piece of c-qur mesh that is flaking on the side with the omega 3 fatty acid.The surgeon was performing a ventral hernia repair and was going to use the mosaic mesh.He removed the mesh for use and noticed that the mesh was flaking.He then gave the product back to the implant coordinator and used another piece.No impact to patient.
Additional Manufacturer Narrative
The mesh was returned and evaluated to determine why the omega 3 fatty acid (o3fa) coating was flaking off the mesh.Upon receipt the mosaic mesh was removed from the clear film that the product is shipped in originally.The mesh showed that the o3fa coating was flaking.There was very little coating in the clear shipping film.None of the residual flaking o3fa was adhered to the clear protective film.The clinician or staff member had written on the mesh with a pen ¿this side down.¿ the mesh does not appear to have been placed through a trocar however there were large areas where the coating was missing.A review of all lot history records for the c-qur mosaic mesh was conducted.All in-process specifications and release criteria were met, including pre-and-post-sterile seal strength testing on the packaging, ftir and coating density testing on the cured coated c-qur mosaic panel, and visual inspection of the coating of the cut sample.No deviations or non-conformances were reported in any of the manufacturing and sterilization processes.All acceptance criteria was met.Clinical evaluation: c-qur mosaic is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.C-qur 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 (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.
Event or Problem Description
N/a.

• Brand Name: C-QUR MOSAIC
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8338073
• Report Number: 3011175548-2019-00171
• Device Sequence Number: 13504421
• Product Code: FTL
• UDI-Device Identifier: 00650862311068
• UDI-Public: 00650862311068
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K121070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: 31106
• Device Catalogue Number: 31106
• Device Lot Number: 419124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1