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

Model Number 31128

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Event Description

The surgeon had completed the implantation of the mesh and he noticed the mesh coating on his gloves.There was no damage noted to the mesh when removing it from the packaging.Staff reported that approximately half of the coating came off but it was in patches and not in localized areas.

Manufacturer Narrative

All in-process specifications and release criteria were met, including pre-and-post-sterile seal strength testing on the packaging, fourier-transform infrared spectroscopy and coating density testing on the cured coated c-qur mosaic panel, and visual inspection of the coating of the cut sample.Ball burst, suture retention (course and wale directions), and ftir testing were conducted on the polypropylene mesh material at incoming and all acceptance criteria was also met.Clinical evaluation: c-qur mosaic mesh is a sterile, knitted polypropylene monofilament mesh material with a non-continuous coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bioabsorbable oil coating).This product is intended for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.The bao coating is absorbable by the body.If in the event the coating 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.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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 10 continental blvd.; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 6431407
• MDR Text Key: 70770068
• Report Number: 3011175548-2017-00010
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862311280
• UDI-Public: 00650862311280
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/24/2018
• Device Model Number: 31128
• Device Catalogue Number: 31128
• Device Lot Number: 401722
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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: 46 YR
• Patient Weight: 76