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

Model Number 31105

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received report that a surgeon had placed mesh into abdomen and flaking of omega 3 fatty acids was noticed after tacking and securing into place.

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.Examination of the returned sample (identical code number and lot number as implanted sample) did not reveal any abnormalities or defects in the coating.The omega 3 fatty acid coating was intact upon removal of the c-qur mosaic mesh from its packaging and after exposure to saline and after cutting/trimming the mesh.Blooming of the coating was noted; however, it is acceptable per the inspection criteria.The sample, from the same lot, returned met all inspection requirements and would have been acceptable for use.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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORP.; 40 continental blvd.; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: theresa morin ; 10 bowman drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 6142182
• MDR Text Key: 61350598
• Report Number: 3011175548-2016-00012
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/27/2018
• Device Model Number: 31105
• Device Catalogue Number: 31105
• Device Lot Number: 401313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• 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
• Treatment: ETHICON SECURESTRAP
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 66