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

Model Number	31536
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
During implantation surgeon placed a tack in the middle of the device and he felt that the mesh appeared "thinner" and a hole was created in the middle of the mesh.Implantation was carried out to completion.No harm to the patient occurred.
Additional Manufacturer Narrative
A review of the complaint details was conducted as well as an image received from the physician.The image showed that a tack had been placed in the center of the mesh that had gone through the mesh.The hole created in the mesh appears to be larger than the tack.If the tack had been placed and then the mesh manipulated it is possible that the tack was pulled through the mesh.The device history records were reviewed to ensure the product was manufactured and inspected properly.The review of the device history records indicates that the product was manufactured and inspected properly.Based on the details of the complaint and image provided, atrium medical cannot conclude that the mesh was at fault.Clinical investigation - c-qur mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (o3fa) composed of fatty acids, lipids and glycerides, coated on the monofilaments.C-qur mesh 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.The instructions for use (ifu) instruct to inspect the mesh product for any noticeable damage to the knit construction of the mesh.Do not use a c-qur mesh that has any noticeable damage or disruption to the knit construction of the mesh as this may lead to device failure.The ifu also 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.

• Brand Name: C-QUR MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7805438
• Report Number: 3011175548-2018-00914
• Device Sequence Number: 16528018
• Product Code: FTL
• UDI-Device Identifier: 00650862315363
• UDI-Public: 00650862315363
• Combination Product (Y/N): N
• Initial Reporter State: MD
• PMA/510(K) Number: K050311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 31536
• Device Catalogue Number: 31536
• Device Lot Number: 425424
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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 Weight: 107