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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameC-QUR MOSAIC
Type of DeviceMESH, 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 Key6142182
MDR Text Key61350598
Report Number3011175548-2016-00012
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121070
Number of Events Reported1
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 Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/27/2018
Device Model Number31105
Device Catalogue Number31105
Device Lot Number401313
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2016 Patient Sequence Number: 1
Treatment
ETHICON SECURESTRAP
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