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

Model Number 31105

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  Injury  

Event Description

Physician reported that after placement of mesh laparoscopic, he sutured the mesh to the body around the edges of the mesh.While suturing, the omega-3-fatty-acid coating started flaking off.

Manufacturer Narrative

(b)(4).Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation: lot history and sterilization records were reviewed.All in-process inspections and testing including but not limited to fourier-transform infrared spectrophotometry (ftir), coating density and pre and post sterile pouch peel.All raw materials met all incoming testing and inspections.The sterilization records were reviewed and passed.Review shows that this lot met all acceptance criteria for lot release.Clinical evaluation: clinical evaluation: c-qur mosiac mesh has a non-continuous coating derived from a biological oil composed of fatty acids, lipids and glycerides (bao bioabsorbable oil coating).It has a coating that is absorbable by the body.The fixation technique, method and products used are left solely to the discretion of the surgeon to optimize clinical outcomes.The instructions for use state under adverse reaction, 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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4947144
• MDR Text Key: 6034657
• Report Number: 1219977-2015-00199
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/27/2018
• Device Model Number: 31105
• Device Catalogue Number: 31105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 108